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Abstract Background A woman with a history of GDM has a high risk of developing type two diabetes (T2DM) in her future life. Lifestyle modifications are known to attenuate the progression of GDM to T2DM. Therefore, the aim of this study was to assess the impact of a simple, cost effective, culturally acceptable lifestyle intervention programme on the trajectory towards T2DM in women with a history of GDM. Methods This cluster randomized trial was conducted in 100 postpartum women in three selected districts of Sri Lanka. The subjects were divided into intervention (n = 50) and control groups (n = 50) by cluster randomization method. A culturally adapted protocol (comprised of dietary and physical activity modifications) was administered to the intervention group. The glycemic profile was assessed using fasting and 2-hour post-OGTT plasma glucose and HbA1c, and insulin resistance by HOMA-IR at baseline and after one year of intervention. Results The mean age (SD) of the subjects in the intervention and control groups were 33.0 (5.1) and 34.3 (6.5) years respectively. All glycemic and insulin resistance parameters (i.e. Fasting plasma glucose- FPG, 2-hour post-OGTT plasma glucose, HbA1c and HOMA-ir) were comparable (p > 0.05) between the two groups at baseline. FPG, 2 h post OGTT, HbA1c and HOMA-ir values between intervention vs. control (p) at 12 months were 87.3 vs. 123.2 (

Abstract Background Evaluation of hypercalcaemia in a patient with chronic kidney disease (CKD) is challenging, especially in low-resource settings. Hormone assays should be interpreted with caution as CKD affects both parathyroid hormone (PTH) and vitamin D. Therapies such as bisphosphonates are contraindicated in CKD, while fluid resuscitation can lead to volume overload. We report the diagnostic workup of a patient with stage V CKD who presented with symptomatic hypercalcaemia and discuss the diagnostic pitfalls and therapeutic challenges. Case presentation A 72-year-old Sri Lankan woman with stage V, non-oliguric CKD presented with a 2-week history of worsening lassitude, increased thirst and constipation. She was clinically euvolemic and did not have signs of uraemia. Bilateral lung fields had occasional coarse crepitations. The rest of the physical examination was normal. Her serum creatinine level was similar to her baseline (4.7 mg/dl, eGFR 9 ml/min). She was found to have a high serum calcium (14.3 mg/dl) and phosphate (5.0 mg/dl) levels. Her PTH level was 24.1 pg/ml (15–68), and she was deficient in 25-hydroxycholecalciferol (9 mg/ml (30–100)). She was not on calcium or vitamin D supplementation. Disseminated tuberculosis was diagnosed after detecting granulomata in the lungs and abdomen in the contrast-enhanced computed tomography (CECT) and mycobacterial DNA in sputum. She was hydrated with 0.9% NaCl with meticulous use of frusemide. The effect of frusemide waned off by the 10th day, requiring haemodialysis to control the hypercalcaemia. Vitamin D was replaced intramuscularly with 200,000 IU, after which the calcium levels increased. She was treated with IV pamidronate 30 mg, and the calcium levels started reducing drastically. Antituberculous therapy (ATT) was initiated 7 days after pamidronate treatment. The calcium levels normalised 2 days after ATT and sustained beyond 2 months. Conclusion Interpretation of PTH and phosphate levels should be done with caution when evaluating hypercalcaemia in patients with advanced chronic kidney disease. First- and second-generation assays detect PTH fragments which accumulate in CKD, leading to false positives. Hypophosphataemic effects of PTH/PTHrP can be masked by accumulation of phosphate in CKD. Bisphosphonates might have a role in treating calcitriol-induced hypercalcaemia, although this needs further evaluation.

Summary: Background: The increasing prevalence of diet-related non-communicable diseases (NCDs) in South Asia is concerning, with type 2 diabetes projected to rise to 68%, compared to the global increase of 44%. Encouraging healthy diets requires stronger policies for healthier food environments. Methods: This study reviewed and assessed food environment policies in Bangladesh, India, Pakistan, and Sri Lanka from 2020 to 2022 using the Healthy Food Environment Policy Index (Food-EPI) and compared them with global best practices. Seven policy domains and six infrastructure support domains were considered, employing 47 good practice indicators to prevent NCDs. Stakeholders from government and non-governmental sectors in South Asia (n = 148) were invited to assess policy and infrastructure support implementation using the Delphi method. Findings: Implementation of food environment policies and infrastructure support in these countries was predominantly weak. Labelling, monitoring, and leadership policies received a moderate rating, with a focus on food safety, hygiene, and quality rather than obesity prevention. Key policy gaps prioritized for attention included front-of-pack labelling, healthy food subsidies, unhealthy food taxation, restrictions on unhealthy food promotion, and improvements in school nutrition standards to combat NCDs. Interpretation: Urgent action is required to expand food policies beyond hygiene and food security measures. Comprehensive strategies targeting NCD prevention are crucial to combat the escalating burden of NCDs in the region. Funding: This research was funded by the NIHR (16/136/68 and 132960) with aid from the UK Government for global health research. Petya Atanasova also acknowledges funding from the Economic and Social Research Council (ESRC) (ES/P000703/1). The views expressed are those of the authors and not necessarily of the NIHR, the UK government or the ESRC.

Abstract Introduction Tobacco use, in both smoking and smokeless forms, is highly prevalent among South Asian adults. The aims of the study were twofold: (1) describe patterns of SLT and combustible tobacco product use in four South Asian countries stratified by country and sex, and (2) assess the relationships between SLT and smoking intensity, smoking quit attempts, and smoking cessation among South Asian men. Methods Data were obtained from South Asia Biobank Study, collected between 2018 and 2022 from 148,944 men and women aged 18 years and above, living in Bangladesh, India, Pakistan, or Sri Lanka. Mixed effects multivariable logistic and linear regression were used to quantify the associations of SLT use with quit attempt, cessation, and intensity. Results Among the four South Asian countries, Bangladesh has the highest rates of current smoking (39.9% for male, 0.4% for female) and current SLT use (24.7% for male and 23.4% for female). Among male adults, ever SLT use was associated with a higher odds of smoking cessation in Bangladesh (OR, 2.88; 95% CI, 2.65, 3.13), India (OR, 2.02; 95% CI, 1.63, 2.50), and Sri Lanka (OR, 1.36; 95% CI, 1.14, 1.62). Ever SLT use and current SLT use was associated with lower smoking intensity in all countries. Conclusions In this large population-based study of South Asian adults, rates of smoking and SLT use vary widely by country and gender. Men who use SLT products are more likely to abstain from smoking compared with those who do not.

The food environment in school neighborhoods plays a crucial role in manipulating the food choices of schoolchildren. This study investigated the relationship between the food environment in neighborhoods and the dietary practices of government school students in a low socioeconomic setting in Sri Lanka. This cross-sectional study surveyed the neighborhood food environment of selected schools (n = 30) in the Monaragala District, Sri Lanka, using geographical information system (GIS) data and collected dietary information from a representative sample of schoolchildren (n = 603). Chi-square and Spearman correlation tests were performed using SPSS version 23.0 to estimate the associations between the food environment and BMI, while ArcGIS 10.4.1 was used to analyze the GIS data. The majority of the students (35.5%) were 15 years old, and approximately 51% were females. The mean BMI of the study participants was 18.14 (±3.28). More than 90% of outlets within proximity sold unhealthy foods. Consumption of confectionaries was 72.3% of the students, whereas healthy food choices ranged from 5% to 12%. A positive correlation between consuming unhealthy food and distance to outlets from school was observed (p

Abstract Background South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care. Methods The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance. Discussion The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP. Ethics and dissemination The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations. Trial registration EudraCT 2016–001,350-18 . Registered on 14 April 2016. ClinicalTrials.gov NCT02949739 . Registered on 31 October 2016.

Introduction: The aim of our study was to investigate the impact of diabetes-related factors on the dental disease outcomes of diabetes patients in Trincomalee, Sri Lanka. Materials and Methods: Dental data were collected from 80 type-2-diabetic individuals. A dental risk score was calculated based on the frequency of dental outcomes observed and categorized as low risk (≤3 dental outcomes) and high risk (>3 dental outcomes). Results: In this cohort of men and women with type 2 diabetes, there was a high frequency of periodontal related outcomes, including missing teeth (70%), gingival recessions (40%), tooth mobility (41%), and bleeding (20%). Thirty-nine (39%) of participants had high dental risk, while forty-nine (61%) had low risk. Conclusions: After controlling for age, participants with higher capillary blood glucose levels had 3-fold greater odds of a high dental risk score (OR = 2.93, 95%CI = 1.13, 7.61). We found that poor glycemic control indicated by elevated capillary blood glucose was associated with increased dental risk.

Abstract Background People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Hypothesis Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. Design Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. Entry criteria South Asian, men or women, age 40–70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0–6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index

Background The global epidemic of type 2 diabetes mellitus (T2DM) renders its prevention a major public health priority. A key risk factor of diabetes is obesity and poor diets. Food environments have been found to influence people’s diets and obesity, positing they may play a role in the prevalence of diabetes. Yet, there is scant evidence on the role they may play in the context of low- and middle-income countries (LMICs). We examined the associations of food environments on T2DM among adults and its heterogeneity by income and sex. Methods and findings We linked individual health outcome data of 12,167 individuals from a network of health surveillance sites (the South Asia Biobank) to the density and proximity of food outlets geolocated around their homes from environment mapping survey data collected between 2018 and 2020 in Bangladesh and Sri Lanka. Density was defined as share of food outlets within 300 m from study participant’s home, and proximity was defined as having at least 1 outlet within 100 m from home. The outcome variables include fasting blood glucose level, high blood glucose, and self-reported diagnosed diabetes. Control variables included demographics, socioeconomic status (SES), health status, healthcare utilization, and physical activities. Data were analyzed in ArcMap 10.3 and STATA 15.1. A higher share of fast-food restaurants (FFR) was associated with a 9.21 mg/dl blood glucose increase (95% CI: 0.17, 18.24; p < 0.05). Having at least 1 FFR in the proximity was associated with 2.14 mg/dl blood glucose increase (CI: 0.55, 3.72; p < 0.01). A 1% increase in the share of FFR near an individual’s home was associated with 8% increase in the probability of being clinically diagnosed as a diabetic (average marginal effects (AMEs): 0.08; CI: 0.02, 0.14; p < 0.05). Having at least 1 FFR near home was associated with 16% (odds ratio [OR]: 1.16; CI: 1.01, 1.33; p < 0.05) and 19% (OR: 1.19; CI: 1.03, 1.38; p < 0.05) increases in the odds of higher blood glucose levels and diagnosed diabetes, respectively. The positive association between FFR density and blood glucose level was stronger among women than men, but the association between FFR proximity and blood glucose level was stronger among men as well as among those with higher incomes. One of the study’s key limitations is that we measured exposure to food environments around residency geolocation; however, participants may source their meals elsewhere. Conclusions Our results suggest that the exposure to fast-food outlets may have a detrimental impact on the risk of T2DM, especially among females and higher-income earners. Policies should target changes in the food environments to promote better diets and prevent T2DM. Dian Kusuma and colleagues investigate the associations between exposure to the density and proximity of healthy and unhealthy food outlets and diabetes in Bangladesh and Sri Lanka. Author summary Why was this study done? With a global prevalence of 9% (463 million people) in 2019, the widespread epidemic of diabetes mellitus renders the prevention of this condition a major priority for public health. Creating health-enabling environments that promote healthy eating and physical activity is needed to reduce the number of people suffering from diabetes. Food environments influence risk factors for type 2 diabetes mellitus (T2DM), but this evidence is understudied among low- and middle-income countries (LMICs). What did the researchers do and find? We examined the associations between the exposure to the density and proximity of healthy and unhealthy food outlets and diabetes (i.e., fasting blood glucose level, high blood glucose, and diagnosed diabetes) using the South Asia Biobank and environment mapping data for 12,167 adults collected between 2018 and 2020 for Bangladesh and Sri Lanka. We found that a higher share of fast-food outlets was associated with a 9.21 mg/dl blood glucose increase. Also, a 1% increase in the share of fast-food outlets was associated with an 8% increase in the probability of being diagnosed with diabetes. Having at least 1 fast-food retailer in the proximity of one’s home was associated with 2.14 mg/dl blood glucose increase. While the association between the density of fast-food retailers and blood glucose level was stronger among women than men, density of fast-food restaurants (FFRs) increased the likelihood of being diagnosed with diabetes for both men and women. The association between proximity to these outlets and blood glucose level was stronger among men. Both density and proximity of fast-food outlets were associated with diabetes outcomes among high-income earners. Density of FFRs was associated with increased probability of being diagnosed with diabetes for low-income earners, although the effect size was smaller than for high-income earners. What do these findings mean? The exposure to fast-food outlets may have a detrimental impact on the risk of diabetes, especially among females and those with higher income. Policies should target changes in the food environments to promote better diets and prevent diabetes.

Introduction: In low-middle income countries (LMICs) the role of food environments on obesity has been understudied. We address this gap by 1) examining the effect of food environments on adults’ body size (BMI, waist circumference) and obesity; 2) measuring the heterogeneity of such effects by income and sex. Methods: This cross-sectional study analysed South Asia Biobank surveillance and environment mapping data for 12,167 adults collected between 2018 and 2020 from 33 surveillance sites in Bangladesh and Sri Lanka. Individual-level data (demographic, socio-economic, and health characteristics) were combined with exposure to healthy and unhealthy food environments measured with geolocations of food outlets (obtained through ground-truth surveys) within 300 m buffer zones around participants' homes. Multivariate regression models were used to assess association of exposure to healthy and unhealthy food environments on waist circumference, BMI, and probability of obesity for the total sample and stratified by sex and income. Findings: The presence of a higher share of supermarkets in the neighbourhood was associated with a reduction in body size (BMI, β = - 3∙23; p

There is an increasing prevalence of diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN) in older people in many countries across the world. Older adults with type 2 DM have a significantly higher incidence of falls compared with their counterparts without DM. This review synthesize published findings on sensorimotor, cognitive, balance and mobility impairments, and their associations with falls in people with DM and DPN. Given the high incidence of falls and resulting serious consequences, systematically assessing fall risk in people with DM may optimize fall prevention strategies and reduce the associated morbidity, mortality and the rehabilitation costs for people with these conditions. These findings indicate balance, gait, sensorimotor and cognitive assessments should be administered to DM patients, especially in those with DPN, to document impairment levels and target interventions to reduce falls and associated morbidity, mortality and rehabilitation costs.

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Background: South Asia has become a major epicentre of the COVID-19 pandemic. Understanding South Asians’ awareness, attitudes and experiences of early measures for the prevention of COVID-19 is key to improving the effectiveness and mitigating the social and economic impacts of pandemic responses at a critical time for the Region. Methods: We assessed the knowledge, behaviours, health and socio-economic circumstances of 29,809 adult men and women, at 93 locations across four South Asian countries. Data were collected during the national lockdowns implemented from March to July 2020, and compared with data collected prior to the pandemic as part of an ongoing prospective surveillance initiative. Results: Participants were 61% female, mean age 45.1 years. Almost half had one or more chronic disease, including diabetes (16%), hypertension (23%) or obesity (16%). Knowledge of the primary COVID-19 symptoms and transmission routes was high, but access to hygiene and personal protection resources was low (running water 63%, hand sanitisers 53%, paper tissues 48%). Key preventive measures were not widely adopted. Knowledge, access to, and uptake of COVID-19 prevention measures were low amongst people from disadvantaged socio-economic groups. Fifteen percent of people receiving treatment for chronic diseases reported loss of access to long-term medications; 40% reported symptoms suggestive of anxiety or depression. The prevalence of unemployment rose from 9.3% to 39.4% (P

Objective To develop a population-specific methodology for estimating glycaemic control that optimises resource allocation for patients with diabetes in rural Sri Lanka.Design Cross-sectional study.Setting Trincomalee, Sri Lanka.Participants Patients with non-insulin-treated type 2 diabetes (n=220) from three hospitals in Trincomalee, Sri Lanka.Outcome measure Cross-validation was used to build and validate linear regression models to identify predictors of haemoglobin A1c (HbA1c). Validation of models that regress HbA1c on known determinants of glycaemic control was thus the major outcome. These models were then used to devise an algorithm for categorising the patients based on estimated levels of glycaemic control.Results Time since last oral intake other than water and capillary blood glucose were the statistically significant predictors of HbA1c and thus included in the final models. In order to minimise type II error (misclassifying a high-risk individual as low-risk or moderate-risk), an algorithm for interpreting estimated glycaemic control was created. With this algorithm, 97.2% of the diabetic patients with HbA1c ≥9.0% were correctly identified.Conclusions Our calibrated algorithm represents a highly sensitive approach for detecting patients with high-risk diabetes while optimising the allocation of HbA1c testing. Implementation of these methods will optimise the usage of resources devoted to the management of diabetes in Trincomalee, Sri Lanka. Further external validation with diverse patient populations is required before applying our algorithm more widely.

Background: The Timed up and Go Test (TUG) is often used as a mobility measure in older people. However, it is unclear whether the TUG is useful for identifying fall risk in people with diabetes mellitus (DM) and which physical and cognitive/psychological factors influence the performance of this test. Objectives: To investigate whether slow TUG times (standard test and when performed with a secondary cognitive task (c-TUG)) are a risk factor for falls in older people with DM and to determine the relative contributions of a range of sensorimotor, balance and cognitive/psychological factors to TUG performance in this population. Methods: Community-dwelling people (n=103, mean age 61.57, SD=6.3) underwent the TUG and c-TUG tests as well as quantitative tests of vision, peripheral sensation, strength, reaction time, balance, cognition, and fear of falling. Participants were then followed up for falls for six months. Results: Negative binomial regression analyses revealed that each 1s increase in TUG and c-TUG times increased the risk of falling by 29% and 13%, respectively. Multiple regression analyses identified vibration sense (p

Mobile phone-based health interventions (mHealth) are viewed as an attractive approach to foster behaviour change, and found to be effective in promoting physical activity and healthy diets. The present study aims to investigate whether mHealth with advice for dietary and lifestyle modifications would reduce 10-year cardio vascular disease (CVD) risk among overweight or obese adults aged 35–64 years in Sri Lanka. A two-group parallel-arm randomized controlled trial (RCT) was conducted in Colombo district, recruiting 1200 individuals aged 35–64 years with a body mass index (BMI) of ≥25 kgm−2. Participants were randomly assigned either to mHealth package (intervention arm, n = 600) or usual care (control arm, n = 600). The intervention package contains a series of dietary and lifestyle improvement messages, a mobile application to register participants, and a web application to deliver these messages. Participants in the intervention arm receive 2 voice and 2 text messages per week to their mobile phones for a period of 12 months. The primary outcome (10-year CVD risk) will be assessed according to sex, age, smoking status, blood pressure, serum cholesterol and glycaemic status. Data are collected at enrollment and after 12 months of intervention on: dietary practices, physical activity, smoking, anthropometry, body composition, blood pressure, fasting plasma glucose, HbA1c and lipid profile. Analysis of effect will be performed by intention-to-treat principle, comparing the outcomes between intervention and control arms. The study resulted in a comprehensive mHealth nutrition and lifestyle package (mHENAL) and successfully completed recruitment and baseline assessment of participants. The message delivery is in progress. Keywords: mHealth, Mobile phone-based, Nutrition intervention, Lifestyle, Cardiovascular disease, Obesity

Abstract Background Explorations into quantifying the inequalities for diabetes mellitus (DM) and its risk factors are scarce in low and lower middle income countries (LICs/LMICs). The aims of this study were to assess the inequalities of DM and its risk factors in a suburban district of Sri Lanka. Methods A sample of 1300 participants, (aged 35–64 years) randomly selected using a stratified multi-stage cluster sampling method, were studied employing a cross sectional descriptive design. The socioeconomic indicators (SEIs) of the individual were education level and occupational category, and at the household level, the household income, social status level and area deprivation level. DM was diagnosed if the fasting plasma glucose was ≥126 and a body mass index (BMI) of > 27.5 kg/m2 was considered high. Asian cut-off values were used for high waist circumference (WC). Validated tools were used to assess the diet and level of physical activity. The slope index of inequality (SII), relative index of inequality (RII) and concentration index (CI) were used to assess inequalities. Results The prevalence of DM and its risk factors (at individual or household level) showed no consistent relationship with the three measures of inequality (SII, RII and CI) of the different indices of socio economic status (education, occupation, household income, social status index or area unsatisfactory basic needs index). The prevalence of diabetes showed a more consistent pro-rich distribution in females compared to males. Of the risk factors in males and females, the most consistent and significant pro-rich relationship was for high BMI and WC. In males, the significant positive relationship with high BMI for SII ranged from 0.18 to 0.35, and RII from 1.56 to 2.25. For high WC, the values were: SII from 0.13 to 0.27 and RII from 1.9 to 3.97. In females the significant positive relationship with high BMI in SII ranged from 0.13 to 0.29, and RII from 2.3 to 4.98. For high WC the values were: SII from 028 to 0.4 and RII 1.99 to 2.39. Of the other risk factors, inadequate fruit intake showed a consistent significant pro-poor distribution only in males using SII (− 0.25 to − 0.36) and in both sexes using CI. Smoking also showed a pro-poor distribution in males especially using individual measures of socio-economic status (i.e. education and occupation). Conclusions The results show a variable relationship between socioeconomic status and prevalence of diabetes and its risk factors. The inequalities in the prevalence of diabetes and risk factors vary depending on gender and the measures used. The study suggests that measures to prevent diabetes should focus on targeting specific factors based on sex and socioeconomic status. The priority target areas for interventions should include prevention of obesity (BMI and central obesity) specifically in more affluent females. Males who have a low level of education and in non-skilled occupations should be especially targeted to reduce smoking and increase fruit intake.

Abstract Background Cinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in healthy adults using a Phase I Clinical Trial. Methods This phase I clinical trial was conducted at the Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka. Thirty healthy adults were recruited for the study, conducted for a period of 3 months, with the dose of CZ (water extract) increased at monthly intervals (85 mg, 250 mg and 500 mg). Data collection was carried out at baseline and during each monthly follow up visit. Anthropometric, clinical and biochemical assessments were done at baseline and during follow up. Adverse effects and drug compliance was also evaluated. Results Twenty eight subjects completed the three months follow up. Mean age was 38.8 ± 10.4 years and 50% were males. There were no significant changes in the anthropometric parameters during the three months follow up. Both systolic and diastolic blood pressure reduced significant during the 1st month and this reduction was sustained throughout follow up. Full blood count, renal function tests, liver function tests, fasting blood glucose, HDL-c, VLDL-d and triglycerides remained within the normal range without any significant alteration during the 3 months. A significant reduction in the TC (p

Abstract Background Previous studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of Cinnamomum zeylanicum extract as a pharmaceutical agent in patients with type-2 diabetes mellitus. Methods/design The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 4 months at the Medical Clinic, University Medical Unit, National Hospital of Sri Lanka. A total of 210 subjects with diabetes, in three equal groups, will be recruited for the study. The patients will be randomized in a 1:1:1 ratio according to the method of block randomization and the subjects will be randomly and equally assigned into two test groups (n = 70 each) and one placebo group (n = 70). The population will be stratified at randomization based on age, gender and disease severity. The treatment drug is a capsule containing Cinnamomum zeylanicum extract as the active ingredient and the placebo capsule will contain lactose monohydrate. Two doses of Cinnamomum zeylanicum extracts (250 mg and 500 mg of the cinnamon extract) will be used. The study drugs will be double blinded to both investigators and participants. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3) and 4 months (visit 4). The following primary outcome measures will be evaluated: glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG) and serum insulin. Secondary outcome measures include: Body Mass Index (BMI) and other anthropometric parameters, blood pressure, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TAG). Data will be analyzed using SPSS version 14. Discussion We describe the protocol for a clinical trial design evaluating the effects of Cinnamomum zeylanicum (Ceylon cinnamon) in patients with type-2 diabetes mellitus. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of cinnamon dietary supplementation in patients with diabetes. Trial registration Sri Lanka Clinical Trials Registry (SLCTR), identifier: SLCTR/2017/010 ( http://slctr.lk/trials/714 ). Registered on 5 April 2017; study protocol version 3.1 21 March 2017.

Southeast Asia faces a diabetes epidemic, which has created significant challenges for health care. The unique Asian diabetes phenotype, coupled with peculiar lifestyle, diet, and healthcare-seeking behavior, makes it imperative to develop clinical pathways and guidelines which address local needs and requirements. From an insulin-centric viewpoint, the preparations prescribed in such pathways should be effective, safe, well tolerated, nonintrusive, and suitable for the use in multiple clinical situations including initiation and intensification. This brief communication describes the utility of premixed or dual action insulin in such clinical pathways and guidelines.

Abstract Background Recent rapid advances in assisted reproductive health technologies enables couples with subfertility to conceive through various intervention. Majority of treatment modalities target the female partner. However it is important to identify and treat male factor subfertility right at the outset. We report a case of isolated follicle stimulating hormone deficiency resulting in azoospermia and primary subfertility. Case presentation A 28 year otherwise healthy male presented with primary subfertility with a healthy female counterpart. He was found to have non obstructive azoospermia with low seminal fluid volume. He had normal external genitalia and potency with increased libido. Further evaluation revealed an isolated deficiency of follicle stimulating hormone with elevated testosterone levels. His luteinizing hormone and prolactin levels were normal. Contrast enhanced CT scan of chest, abdomen and pelvis and MRI scan of the pituitary fossa were normal too. Conclusion In the era of modern reproductive technology it is important to further evaluate males with non-obstructive azoospermia to detect underlying gonadotropin deficiency.

Since their introduction in clinical practice in the 1950′s, Sulfonylureas (SUs) have remained the main-stay of pharmacotherapy in the management of type 2 diabetes. Despite their well-established benefits, their place in therapy is inappropriately being overshadowed by newer therapies. Many of the clinical issues associated with the use of SUs are agent-specific, and do not pertain to the class as such. Modern SUs (glimepiride, gliclazide MR) are backed by a large body of evidence, experience, and most importantly, outcome data, which supports their role in managing patients with diabetes. Person-centred care, i.e., careful choice of SU, appropriate dosage, timing of administration, and adequate patient counseling, will ensure that deserving patients are not deprived of the advantages of this well-established class of anti-diabetic agents. Considering their efficacy, safety, pleiotropic benefits, and low cost of therapy, SUs should be considered as recommended therapy for the treatment of diabetes in South Asia. This initiative by SAFES aims to encourage rational, safe and smart prescription of SUs, and includes appropriate medication counseling.

DOI: http://dx.doi.org/10.4038/sjdem.v3i2.6382 Sri Lanka Journal of Diabetes, Endocrinology and Metabolism 2013; 3: 114-122

Aim: Worldwide obesity levels have increased unprecedentedly over the past couple of decades. Although the prevalence, trends and associated socio-economic factors of the condition have been extensively reported in Western populations, less is known regarding South Asian populations. Methods: A review of articles using Medline with combinations of the MeSH terms: ‘Obesity', ‘Overweight' and ‘Abdominal Obesity' limiting to epidemiology and South Asian countries. Results: Despite methodological heterogeneity and variation according to country, area of residence and gender , the most recent nationally representative and large regional data demonstrates that without any doubt there is a epidemic of obesity, overweight and abdominal obesity in South Asian countries. Prevalence estimates of overweight and obesity (based on Asian cut-offs: overweight ≥ 23 kg/m2, obesity ≥ 25 kg/m2) ranged from 3.5% in rural Bangladesh to over 65% in the Maldives. Abdominal obesity was more prevalent than general obesity in both sexes in this ethnic group. Countries with the lowest prevalence had the highest upward trend of obesity. Socio-economic factors associated with greater obesity in the region included female gender, middle age, urban residence, higher educational and economic status. Conclusion: South Asia is significantly affected by the obesity epidemic. Collaborative public health interventions to reverse these trends need to be mindful of many socio-economic constraints in order to provide long-term solutions.

DOI: http://dx.doi.org/10.4038/sjdem.v3i1.5505 Sri Lanka Journal of Diabetes, Endocrinology and Metabolism 2013; 3: 45-37

Asia is home to four of the world′s five largest diabetic populations, two of them being South Asian nations, namely, India and Pakistan. This problem is compounded by a substantial rise in the elderly population in Asian countries. On the other hand, the heterogeneous health condition and multiple co-morbidities make the care of chronic disease in the elderly a challenging task. The aim of the South Asian Consensus Guidelines is to provide evidence-based recommendations to assist healthcare providers in the rational management of type 2 diabetes mellitus in the elderly population. Current Guidelines used systematic reviews of available evidence to form its key recommendations. No evidence grading was done for the purpose of this manuscript. The clinical questions of the guidelines, the methodology of literature search, and medical writing strategy were finalized by consultations in person and through mail. The South Asian Consensus guideline emphasizes tailoring of glycemic goals for patients based on age, co-morbid conditions especially that of cardiovascular system, risk of hypoglycemia, and life expectancy. It also recommends cautious use of available pharmacotherapy in geriatric patients with diabetes. The primary principle of diabetes therapy should be to achieve euglycemia, without causing hypoglycemia. Appropriate use of modern insulins and oral drugs, including incretin mimetics will help physicians achieve this aim.

As newer methods of management are made available, and accessible, survival rates with human immunodeficiency virus (HIV) are increasing. This means that chronic, metabolic complications of HIV are becoming more frequent in clinical practice, as acute morbidity is controlled. Management of HIV/acquired immunodeficiency syndrome (AIDS) is gradually expanding to include these chronic and metabolic complications of the disease, and the adverse effects associated with its treatments, including diabetes. Unfortunately, no guidelines are available to help the medical practitioners choose appropriate therapy for patients with these conditions. The aim of the South Asian Consensus Guidelines is to provide evidence-based recommendations to assist healthcare providers in the rational management of type 2 diabetes mellitus in patients with HIV. The development of these guidelines used systematic reviews of available evidence to form its key recommendations. These guidelines and associated review of literature represent a compilation of available knowledge regarding rational management of diabetes in HIV. Patients of diabetes with concomitant HIV infection are managed optimally with insulin therapy and judicious use of highly active antiretroviral therapy with suitable alternatives is also recommended. These guidelines should prove helpful to physicians, not only in South Asia, but also across the globe, while managing patients with coexistent HIV and diabetes.

48,XXYY is a rare sex chromosome aneuploidy affecting 1 in 18,000 to 50,000 male births. They present with developmental delay, hypogonadism, gynecomastia, intention tremors, and a spectrum of neurodevelopmental and psychiatric disorders. At one time this condition was considered a variant of Klinefelter syndrome. In clinically suspected cases, 48,XXYY syndrome can be diagnosed by chromosome culture and karyotyping. This patient presented with hypergonadotrophic hypogonadism, attention deficit hyperactive disorder, and renal malformatons. Klinefelter syndrome was clinically suspected. The karyotype confirmed the diagnosis of 48,XXYY syndrome. This is the first reported case of 48,XXYY syndrome from Sri Lanka.

DOI: http://dx.doi.org/10.4038/sjdem.v4i1.7260 Sri Lanka Journal of Diabetes, Endocrinology and Metabolism 2014; 4: S1-S12

Most studies seeking common variant associations with type 2 diabetes (T2D) have focused on individuals of European ancestry. These discoveries need to be evaluated in other major ancestral groups, to understand ethnic differences in predisposition, and establish whether these contribute to variation in T2D prevalence and presentation. This study aims to establish whether common variants conferring T2D-risk in Europeans contribute to T2D-susceptibility in the South Asian population of Sri Lanka.Lead single nucleotide polymorphism (SNPs) at 37 T2D-risk loci attaining genome-wide significance in Europeans were genotyped in 878 T2D cases and 1523 normoglycaemic controls from Sri Lanka. Association testing was performed by logistic regression adjusting for age and sex and by the Cochran-Mantel-Haenszel test after stratifying according to self-identified ethnolinguistic subgroup. A weighted genetic risk score was generated to examine the combined effect of these SNPs on T2D-risk in the Sri Lankan population.Of the 36 SNPs passing quality control, sixteen showed nominal (p

Sri Lanka Journal of Diabetes, Endocrinology and Metabolism 2012; 2: S1-S20 DOI: http://dx.doi.org/10.4038/sjdem.v2i2.4786