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Background: The current study aims to assess cardiovascular risk factors (CVRFs) among diabetic versus nondiabetic nonalcoholic fatty liver disease (NAFLD) patients. NAFLD is the most common hepatic disorder worldwide which is directly associated with diverse CVRFs such as type 2 diabetes mellitus (T2DM) and metabolic syndrome (MS)., Materials and Methods: The current cross-sectional population-based study has been conducted on 1031 NAFLD patients. After excluding 340 prediabetes patients, the NAFLD patients were divided into T2DM and normal blood glucose (NBG). Then, CVRFs were compared between the two groups., Results: Out of 691 NAFLD cases included in the study, 337 (48.8%) patients had T2DM. In the T2DM and NBG groups, the body mass index (BMI) was 31.2 ± 4.6 and 29.9 ± 4.3 kg/m2, respectively (P = 0.001). The waist circumference was 102.2 ± 10.2 and 97.6 ± 10.6 cm, respectively (P < 0.001). The systolic blood pressure was 123.3 ± 15.6 and 119.6 ± 13.6 mmHg, respectively (P = 0.043). The triglyceride levels were 191.9 ± 104.7 and 176.5 ± 89.6 mg/dL, respectively (P = 0.042). Generally, these factors were significantly higher among the diabetic patients. Besides, cardiovascular disease (CVD), hypertension, and MS were statistically more prevalent in NAFLD patients with T2DM ( P < 0.001) than nondiabetic NAFLD patients. In multiple logistic regression models, the odds ratio of CVD, hypertension, and MS was 2.18, 2.12, and 6.63 for patients with T2DM compared with NBG, respectively. Adjustment was made for age, sex, BMI, smoking, and physical activity., Conclusion: CVRFs were higher in NAFLD patients with T2DM than NAFLD patients with NBG., Competing Interests: There are no conflicts of interest., (Copyright: © 2024 Journal of Research in Medical Sciences.)

The potential link between dysbiosis, features of metabolic syndrome (MetS), inflammation, and sensation impairment has been recently recognized. However, in this context, there are few indications available regarding the effects of co-supplementation with Bacillus indicus , Bacillus coagulans , and fructooligosaccharide (FOS) prebiotics on patients with MetS. Therefore, this study aimed to investigate the effects of synbiotic supplementation on glycemic indices, inflammatory biomarkers, and appetite among adults with MetS. This study is a randomized, double-blind, placebo-controlled clinical trial conducted in the Endocrine and Metabolism Research Center outpatient clinic in Isfahan, Iran. Fifty-eight MetS patients were randomly assigned to receive either synbiotics ( n  = 29) or placebo ( n  = 29) supplementation twice per day for 8 weeks. Finally, 55 patients were recruited for analyses (28 in the intervention group and 27 in the placebo group). Random permuted blocks and a computer-generated random number table were used for treatment allocation. No adverse effects were reported during the study. There were no significant differences in glycemic indices and inflammatory markers within- and between groups (all p  > .05). However, a significant increase in the sensation of fullness was documented in the synbiotic group. In conclusion, the eight-week treatment did not improve glycemic control and inflammatory markers. Nevertheless, it demonstrated potential efficacy in enhancing participants' appetite sensations, warranting further evaluation in longer intervention periods during future clinical trials., Competing Interests: The authors declare no conflict of interest., (© 2024 The Authors. Food Science & Nutrition published by Wiley Periodicals LLC.)

Background: Osteoporosis is a skeletal and bone disorder characterized by bone fractures and decreased bone mineral density (BMD). Bisphosphonates have a great tendency to bind to minerals, and their long-term use can increase the risk of bone fragility in patients. Stopping bisphosphonates after a period of time is called a drug holiday (DH). Recent evidence has shown that patients' BMD may decrease again during DH. However, few studies have been done in this regard. In the present study, we compared the BMD of postmenopausal women during bisphosphonates treatment and 1 year after DH., Material and Methods: A total of 202 patients were selected with osteopenia (n = 95) and osteoporosis (n = 107); they had been treated with alendronate for 5 years (a rheumatologist confirmed the diagnosis of osteopenia and osteoporosis) and had undergone DH for 1 year. At the arrival of all patients, BMD was checked with the DXA (dual-energy X-ray absorptiometry) method using the 2007 American Explorer model Hologic device based on the Caucasian race. One year later, patients were reassessed for BMD by the same device., Result: The analysis of femoral neck (FN) and lumbar spine (LS) T-score indices in the osteopenia and the osteoporosis groups showed reduction after DH, and the difference was statistically significant in both groups (p = 0.001). After 1 year of stopping bisphosphonate treatment, the average of FN and LS BMD decreased in both groups (p = 0.001)., Conclusion: In general, it can be said that DH can reduce FN and LS T-scores. The results indicated a significant reduction in BMD after the DH period for both the osteoporosis and osteopenia groups in the early months. Also, the effect of DH in osteoporosis patients was more compared to the osteopenia individuals, which could have implications for their treatment approach, and also its effect on bone health. Key Points • The DH can reduce FN and LS T-scores • The BMD reduced after the DH period for both the osteoporosis and osteopenia groups • After 1 year of stopping bisphosphonate treatment, the average of FN and LS BMD decreased in both groups., (© 2024. The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR).)

Background: Primary hypothyroidism is a common endocrine disorder caused by impaired production of thyroid hormones. Recent studies have shown that dietary habits, oxidative stress, and inflammation may play roles in thyroid hypofunction. Thus, the present article aimed to determine the relationship between major dietary patterns and oxidative stress and inflammation in primary hypothyroid patients and healthy people in Iranian adults., Methods: This matched case-control study was conducted on 200 participants (100 cases and 100 controls). The presence of primary hypothyroidism was determined by endocrinologists based on American Thyroid Association (ATA) criteria. Dietary intake was assessed using a validated 168-item, semi-quantitative food frequency questionnaire (FFQ). The principal component analysis (PCA) method was used to derive major dietary patterns. Statistical analysis was performed using logistic regression analysis, and the findings were reported using odds ratios (ORs) with 95% CIs., Results: We identified 2 major dietary patterns (i.e., healthy and Western dietary patterns). After adjusting for confounding variables, participants in the highest tertile of the healthy eating pattern had lower odds of primary hypothyroidism. Also, there was a significant relationship between total antioxidant capacity (TAC) levels and thyroid hypofunction; however, no significant correlation was seen between the Western dietary pattern and malondialdehyde (MDA) and C-reactive protein (CRP) with hypothyroidism., Conclusions: There were statistically direct associations between healthy dietary patterns (loaded with vegetables, nuts and seeds, fruits, dried fruits, olives, garlic, black pepper, starchy vegetables, low-fat dairy, and legumes) and increased TAC levels with a decreased risk of thyroid hypofunction. However, Western dietary patterns and MDA and CRP levels did not associate with an underactive thyroid., (© 2023. The Author(s).)

Objective: Pharmacological treatments of osteoarthritis (OA) have several side effects. Boswellia serrata resin (frankincense) is rich in boswellic acids that have antioxidant and anti-inflammatory effects; though, their oral bioavailability is low. The aim of this study was evaluation of the clinical effectiveness of frankincense extract in the treatment of knee OA. In a randomized double-blind placebo-controlled clinical trial, eligible patients with knee OA were randomly divided into two groups of drug (33 patients) and control (37 patients), to use oily solution of frankincense extract or placebo, respectively, on the involved knee three times daily for four weeks. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), VAS (visual analogue scale; for pain severity), and PGA (patient global assessment) scores were determined before and after intervention., Results: For all evaluated outcome variables, there was a significant decrease from baseline in both groups (P < 0.001 for all). Furthermore, the end-of-intervention values for all parameters were significantly lower in drug group than placebo group (P < 0.001 for all), showing more effectiveness of drug compared to placebo., Conclusion: Topical oily solution containing enriched extract of boswellic acids could decrease pain severity and improve the function in patients with knee OA. Trial Registration Trial registration number: IRCT20150721023282N14. Trial registration date: September 20, 2020. The study was retrospectively registered in Iranian Registry of Clinical Trials (IRCT)., (© 2023. The Author(s).)

The aim of the present study was to investigate the effect of linagliptin on microalbuminuria in patients with diabetic nephropathy (DN). The present double-blind randomized placebo-controlled clinical trial was performed on 92 patients with DN who were divided into two groups. The intervention and control groups received linagliptin 5 mg and placebo for 24 weeks, respectively. Blood pressure, lipid profile, liver enzymes, fasting plasma glucose (FPG), and urine albumin-creatinine ratio (UACR) were assessed and recorded before, 12 weeks, and 24 weeks after the beginning of the intervention. The mean value of UACR decrease was significant over time in both groups, with higher decrease in linagliptin group, however, the differences between two groups were not, statistically significant (P > 0.05). However, the percentage of improvement in microalbuminuria (UACR < 30 mg/g) in the linagliptin group was significantly higher than that of the control group during 24 weeks of intervention (68.3% vs. 25%; P-value < 0.001). There was no statistically significant difference in the mean value of the UACR and other parameters between linagliptin treated and placebo treated patients with diabetic nephropathy. Further studies, with longer periods of follow-up are suggested to examine these patients' renal outcomes., (© 2023. The Author(s).)

Background: The oxidative stress caused by the creation and breakdown of reactive oxygen species affects glucose tolerance, B-cell function, insulin resistance, and metabolites containing free fatty acids. Functioning foods are therefore becoming increasingly popular because they provide health benefits and prevent oxidative stress. This research aims to assess strategies to alleviate oxidative stress and inflammation in patients with type 2 diabetes (T2DM). In the present study, the metabolic effect wheat bread fortified with pomegranate peel powder(PPP) will be assessed in participants with type 2 diabetes., Methods: A randomized, triple-blind, placebo-controlled, and parallel arms clinical trial will be conducted on 90 patients with T2DM. Run-in courses will last for two weeks. The intervention and control groups will receive wheat bread with and without PPP, respectively. Anthropometric data, fasting plasma glucose, hemoglobin A1C, lipid profile, insulin level, high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), Total antioxidant capacity(TAC), and mood state, will be measured at the baseline and three months post-intervention. Beta-cell function (HOMA-B) and insulin resistance (HOMA-IR) will also be assessed., Discussion: This trial will provide novel data on the impact of fortified bread with PPP on metabolic profile and mood state of patients with type 2 diabetes. The results will demonstrate the potential of such intervention in glycemic indices, antioxidant status, inflammation and mood in these patients., Trial Registration: Trial is registered in the Iranian Registry of Clinical Trials (ID: IRCT20191209045672N1). Date of registration 21/09/2020. https://en.irct.ir/trial/48132., Competing Interests: Conflict of interestsThe authors declare that they have no conflict of interest., (© The Author(s), under exclusive licence to Tehran University of Medical Sciences 2022. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)

Background: Recently, genome-wide association studies (GWAS) have discovered several single nucleotide polymorphisms (SNPs) and loci associated with the risk of systemic lupus erythematosus (SLE). rs6445975 (T>G; intronic variant) polymorphism in the PXK gene is one of these loci. However, there was an inconsistency between the results of replicative studies on European and Asia ancestry. This study aimed to assess the possible association between rs6445975 polymorphism with SLE risk in the Iranian population., Methods: Genotype and allele distribution of rs6445975 polymorphism were investigated in 110 patients with SLE and 115 healthy controls in Isfahan University of Medical Sciences, Isfahan, Iran in 2019 via real-time PCR high resolution melting method (HRM)., Results: GG and TG genotypes, but not TT genotype, were associated with increased risk of SLE (GG vs TT; OR= 7.538; 95%CI [3.47, 17.066] and TG vs TT; OR=2.21; 95%CI [1.06, 4.72]). Inheritance analysis revealed that TG + GG was correlated with the increased risk of SLE disease in the dominant model (OR=3.928; 95%CI [2.056, 7.74]). Moreover, subjects with the G allele were more frequently affected with SLE than individuals with the T allele (OR= 3.55; 95%CI [2.37, 5.36]). The G allele in patients was correlated with serum concentration of CRP, ESR, anti-dsDNA antibody, C3, and C4 and presentation of some clinical manifestations such as kidney involvements and skin lesions ( P <0.05)., Conclusion: Our findings suggest a substantial association between rs6445975 polymorphism in the PXK gene with susceptibility and clinical characteristics of SLE in the Iranian population., Competing Interests: Conflict of interest The authors declare that there is no conflict of interest., (Copyright © 2022 Karimifar et al. Published by Tehran University of Medical Sciences.)

Background: Sjogren's syndrome, as a chronic autoimmune disease, involves in lymphocytic infiltration in the exocrine glands. As the result of exocrine glands disruption, the clinical hallmark of this disease including dryness of mouth and eyes along with fatigue and joint pain occur. However, heterogeneity of clinical presentations among newly diagnosed adult patients with Sjogren's syndrome leads to difficulty in its diagnosis. One of the diagnostic criteria for Sjogren's syndrome is the presence of autoantibodies in patient serum. One of the novel biomarkers suggested for diagnosis of Sjogren is alpha-fodrin antibody. In this study, we aimed to evaluate the diagnostic power of anti-α-fodrin antibody among the Iranian population for the first time., Materials and Methods: We recruited 82 individuals in this study. Alpha-fodrin were measured in case and control with Elisa kit as 16.71 (9.84) and 18.44 (11.54)., Results: There was no any significant difference between two groups regarding alpha-fodrin level ( P = 0.35). Then we applied the receiver operating characteristic (ROC) curve analysis to determine the predictive value of alpha-fodrin for diagnosing Sjogren's disease. The area under curve of the ROC curve was calculated as 0.5453. Also, there were significant association between age and alpha-fodrin antibody., Conclusions: Alpha-fodrin test did not have acceptable predictive power for predicting Sjogren's disease; however, it could be associated with disease progression., Competing Interests: There are no conflicts of interest., (Copyright: © 2022 Advanced Biomedical Research.)

Objectives: Herbals, as bioactive foods, have been one of the most popular alternatives and complementary treatments in preventing and controlling type 2 diabetes mellitus (T2DM). The aim of the present trial was to examine the effects of wheat germ consumption on mental health and brain-derived neurotrophic factor (BDNF) among patients with T2DM. Methods: Eighty participants with T2DM were randomly allocated to receive 20 g wheat germ ( n  = 40) or placebo ( n  = 40) in a randomized double-blind clinical trial for 12 weeks. Depression, anxiety, stress scale-21 (DASS-21) questionnaire was used to assess the mental health of study participants. Serum BDNF was assessed at the baseline and end of intervention. Anthropometric indices were measured at the baseline, 6 and 12 weeks during the intervention. Results: A total of 75 subjects completed the trial. Compared with the placebo, wheat germ consumption led to a significant reduction in depression ( P  = .03) and stress ( P  = .04) scores. Moreover, a significant increase in serum BDNF concentrations was observed in the wheat germ group ( P  = .004), while there was no significant difference between the groups. Wheat germ intake had no significant effects on anthropometric indices and anxiety scores between the groups. Conclusion: Our findings showed that wheat germ consumption for 12 weeks could significantly reduce the stress and depression scores but had no significant effects on anxiety scale and anthropometric outcomes in patients with T2DM.