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BODY-Q is a patient-reported outcome measure for comprehensive assessment of outcomes specific to patients undergoing bariatric surgery. The clinical utility of BODY-Q is hampered by the lack of guidance on score interpretation. This study aimed to determine minimal important difference (MID) for assessment of BODY-Q. Prospective BODY-Q data from Denmark and the Netherlands pre- and post-bariatric surgery were collected. Two distribution-based methods were used to estimate MID by 0.2 standard deviations of baseline scores and the mean standardized response change of scores from baseline to 3-years postoperatively. In total, 5476 assessments from 2253 participants were included of which 1628 (72.3%) underwent Roux-en-Y gastric bypass, 586 (26.0%) sleeve gastrectomy, 33 (1.5%) gastric banding, and 6 (0.03%) other surgeries. The mean age was 45.1 ± 10.9 with a mean BMI of 46.6 ± 9.6. Baseline MID ranged from 1 to 4 in health-related quality of life (HRQL) and from 2 to 8 in appearance scales. The mean change of scores ranged from 4 to 5 in HRQL and from 4 to 7 in the appearance scales. The estimated MID for the change in BODY-Q HRQL and appearance scales ranged from 3 to 8 and is recommended for use to interpret BODY-Q scores and assess treatment effects in bariatric surgery., (© 2024 The Author(s). Clinical Obesity published by John Wiley & Sons Ltd on behalf of World Obesity Federation.)

Background: Chronic postsurgical pain (CPSP) presents a considerable healthcare challenge, impacting patients, and healthcare providers, particularly in the context of gastrointestinal surgery. The notable incidence of CPSP in this specific surgical domain emphasizes the need to identify patients with a high risk of developing this condition. Despite various studies exploring this topic, a comprehensive systematic review focusing on prognostic factors of CPSP following gastrointestinal surgery is currently lacking. Therefore, the aim of this systematic review is, through systematically examination of existing literature, to assess both established and potentially novel prognostic factors, associated with CPSP following gastrointestinal surgery., Methods: Adhering to the Cochrane Handbook and the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) checklist, we will use pre-established criteria based on Population, Intervention, Comparator, Outcome, Timing, and Setting (PICOT-S), to determine eligibility for inclusion. Essentially, this entails studies reporting on prognostic factors of CPSP following gastrointestinal surgery. Relevant studies will be identified through systematic searches in medical databases, examination of reference lists from included studies, and screening of Clinicaltrials.gov. No restrictions will be imposed regarding language, publication time or source, and both randomized trials and observational studies will be included. Data extraction will follow the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of prognostic factor studies (CHARMS-PF) and for quality assessment, we will use the Quality in Prognosis Studies (QUIPS) tool., Results: The aim for the systematic review is to identify and assess the prognostic value of potential factors for the development of CPSP following gastrointestinal surgery., Conclusion: By creating a comprehensive overview of important prognostic factors for the development of CPSP following gastrointestinal surgery, the findings of this systematic review have the potential to guide future research and to enhance patient information resources., (© 2024 Acta Anaesthesiologica Scandinavica Foundation.)

Aim: To compare nocturnal glucose profiles according to hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100 in a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia., Materials and Methods: The HypoDeg trial is a 2-year investigator-initiated, randomized, controlled crossover trial in 149 participants randomized to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this predefined substudy stayed at least one night in hospital during each treatment arm for plasma glucose samples to be taken. Endpoints were glucose profiles, including mean plasma glucose, glycaemic variability and risk of hypoglycaemia., Results: There were no differences between treatments regarding mean plasma glucose. We saw a flatter glucose profile during insulin degludec compared with insulin glargine U100 treatment, which had a nadir at 4:00 AM, with a subsequent rise. During treatment with insulin degludec, the participants had lower glycaemic variability, with an estimated treatment difference of -4.3% (95% confidence interval [CI] -8.1 to -0.5; P < 0.05). Participants treated with insulin degludec were less likely to experience nocturnal hypoglycaemia below 3.0 mmol/L (hazard ratio 0.36 [95% CI 0.17-0.73; P < 0.05])., Conclusion: Based on nocturnal plasma glucose measurements, treatment with insulin degludec compared with insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose., (© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Aim: To investigate whether the long-acting insulin analogue insulin degludec compared with insulin glargine U100 reduces the risk of nocturnal symptomatic hypoglycaemia in patients with type 1 diabetes (T1D)., Methods: Adults with T1D and at least one episode of nocturnal severe hypoglycaemia during the last 2 years were included in a 2-year prospective, randomized, open, multicentre, crossover trial. A total of 149 patients were randomized 1:1 to basal-bolus therapy with insulin degludec and insulin aspart or insulin glargine U100 and insulin aspart. Each treatment period lasted 1 year and consisted of 3 months of run-in or crossover followed by 9 months of maintenance. The primary endpoint was the number of blindly adjudicated nocturnal symptomatic hypoglycaemic episodes. Secondary endpoints included the occurrence of severe hypoglycaemia. We analysed all endpoints by intention-to-treat., Results: Treatment with insulin degludec resulted in a 28% (95% CI: 9%-43%; P = .02) relative rate reduction (RRR) of nocturnal symptomatic hypoglycaemia at level 1 (≤3.9 mmol/L), a 37% (95% CI: 16%-53%; P = .002) RRR at level 2 (≤3.0 mmol/L), and a 35% (95% CI: 1%-58%; P = .04) RRR in all-day severe hypoglycaemia compared with insulin glargine U100., Conclusions: Patients with T1D prone to nocturnal severe hypoglycaemia have lower rates of nocturnal symptomatic hypoglycaemia and all-day severe hypoglycaemia with insulin degludec compared with insulin glargine U100., (© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Prothrombotic and metabolic variables are decreased after obesity surgery, and fibrin clot lysis is increased. It is unknown how fibrinolytic variables are affected, and whether fibrinolytic and metabolic changes predict the enhanced clot lysis. Study aims were to determine fibrinolytic biomarkers before and 6 months after Roux-en-Y gastric bypass (RYGB) and to identify predictors of the RYGB-induced increase in clot lysis. Women (n = 42) and men (n = 18) with obesity underwent RYGB, and factor XIII (FXIII), thrombin activatable fibrinolysis inhibitor (TAFI), plasminogen and plasmin inhibitor (PI) were measured before and 6 months after surgery. Regression analyses identified determinants of the RYGB-induced increase in clot lysis among changes in fibrinogen and in fibrinolytic and metabolic variables. Results showed that after RYGB, FXIII, TAFI, plasminogen and PI were reduced (P < .0005). Reductions in PI (β = -0.59) and fibrinogen (β = -0.35), together with age (β = -0.22) and male sex (β = 0.22), predicted the enhanced clot lysis with the model explaining 56% (P < .0005). Predictors of the reduction in PI were reductions in cholesterol (β = 0.37) and glucose (β = 0.29), together with male sex (β = -0.28), whereas reductions in fibrinogen were predicted by lowering of interleukin-6 (IL-6) (β = 0.32). In conclusion, fibrinolytic variables were reduced 6 months after RYGB. Targeting PI and fibrinogen, by reducing metabolic variables such as glucose, cholesterol and IL-6, has a profibrinolytic effect in obesity., (© 2020 World Obesity Federation.)

Bariatric surgery induces significant and sustained weight loss and subsequently reduces obesity-related comorbidities. However, only a small percentage of patients with severe obesity undergo bariatric surgery in Denmark. There is limited knowledge about the experiences with and possible reservations to bariatric surgery among secondary healthcare providers. The aim of this cross-sectional study was to investigate referral patterns and knowledge regarding the criteria for bariatric surgery among Danish secondary healthcare providers, treating obesity-related diseases. A questionnaire regarding experiences with and reservations to referring patients for consideration for bariatric surgery, along with thoughts to specific patient cases were sent to several specialists: endocrinologists, obstetricians and gynaecologists, orthopaedic surgeons and otorhinolaryngologists. Most questions required responses on a 5-point Likert scale and frequency distributions were calculated. A total of 345 (44%) specialists responded to the questionnaires. Good knowledge of the criteria for referral to bariatric surgery varied among the specialist from 6% to 68%. One of the main issues was a concern about the medical and surgical postoperative complications, which was a barrier to and influenced referral decisions. Furthermore, specialists were more likely to refer patients to bariatric surgery when patients requested this. Except for endocrinologists, the Danish secondary healthcare specialists interviewed have limited knowledge about bariatric surgery, which results in a reluctance in referring patients. Our results indicate that there is a need to improve knowledge among specialists, regarding the indications, criteria and outcomes for bariatric surgery to establish a more pro-active, specialist led approach to referrals., (© 2020 World Obesity Federation.)

This study compared the measurement properties of the Moorehead-Ardelt quality of life questionnaire-II (MAQOL-II) and the BODY-Q, to determine which was more suitable for measuring patient-reported outcome (PRO) in Danish bariatric surgery (BS) and body contouring surgery (BC) patients. We examined content validity against the COSMIN guidelines and compared psychometric performance using Rasch measurement theory methods and criteria. MAQOL-II data were obtained from the Danish Bariatric Surgery Database from September 2010 to November 2017, and BODY-Q data were collected from June 2015 to March 2018. The MAQOL-II failed to meet recommended standards for content validity, while all criteria were met for the BODY-Q. A total of 16 965 MAQOL-II and 2259 BODY-Q assessments were obtained. A random sample was selected from the MAQOL-II dataset to match the BODY-Q sample. Psychometrically, the BODY-Q performed better than the MAQOL-II. For example, Cronbach's α was 0.82 for the MAQOL-II vs ≥0.90 for all BODY-Q scales. Fifty percent (3/6) of MAQOL-II items had disordered thresholds, while all BODY-Q items had ordered thresholds (123/123). Poor item fit was revealed for 17% (1/6) of MAQOL-II and 8% (10/123) of BODY-Q items. For scale reliability, person separation index was 0.79 for the MAQOL-II and 0.88 (0.81-0.93) for the BODY-Q. In conclusion, the MAQOL-II does not meet today's standards for a rigorously developed PRO measure. The BODY-Q, on the other hand, gives substantial, accurate and interpretable measurement and should be recommended for use in PRO in BS and BC patients., (© 2020 World Obesity Federation.)

Aim: We investigated children's counter regulatory hormone profiles during a hyperinsulinaemic hypoglycaemic clamp procedure at day and night., Methods: In 2013, we assessed the counter regulatory response to hypoglycaemia in eight outpatients with type 1 diabetes, recruited from the Herlev Hospital, Denmark, at a mean age of 9.6 ± 2.3 years. Hyperinsulinaemic 80 mU/m 2 /min clamps were performed with a stepwise reduction in plasma glucose from euglycaemia (7-9 mmol/L) to hypoglycaemia (<3.5 mmol/L) and the glucose nadir (≤2.2 mmol/L) during the day and night. Adrenaline, cortisol, glucagon and growth hormone levels were assessed., Results: Adrenaline and growth hormone levels were higher during the day versus the night (p = 0.04 and p = 0.01, respectively). However, at the glucose nadir, the level of adrenaline was lower during the night than the day (0.6 ± 0.2 versus 1.9 ± 0.5 nmol/L, p = 0.016) and cortisol was lower during the day than the night (42 ± 15 versus 319 ± 81 nmol/L, p = 0.016). No differences were demonstrated for glucagon and growth hormone levels based on the same criteria., Conclusion: The adrenaline response was blunted during nocturnal iatrogenic hypoglycaemia in our study cohort, and no increase in cortisol levels was demonstrated., (©2018 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.)

Obesity and physical inactivity are major health problems. Roux-en-Y gastric bypass (RYGB) surgery results in significant weight loss and reduces obesity-related morbidity and mortality. Physical activity lowers the risk of cardiovascular disease and premature death. The aims of this study were to elucidate the effects of RYGB followed by 6 months of supervised physical training on physical capacity. In a randomized controlled trial, 60 participants eligible for RYGB were randomized 6 months post-surgery to either two weekly physical training sessions for 26 weeks (INT) or a control group (CON). Aerobic capacity (VO 2 max), muscle strength (MS) of the shoulder and hip and physical function were measured pre-surgery and 6, 12 and 24 months post-surgery. RYGB per se decreased MS in all tested muscle groups, had no effects on VO 2 max but improved physical function. After the intervention, INT had a significant 0.33 L min -1 increase in VO 2 max compared to CON (95% CI: 0.07-0.57, P = 0.013). Furthermore, MS in the hip adductor increased significantly with 13 N (95% CI: 3.6-22.4, P = 0.007) and a between-group difference was found in the Stair Climb Test (0.46 repetitions [95% CI: 0.02-0.91, P = 0.042]). The effects were not maintained at follow-up. Supervised physical training following RYGB improved VO 2 max, hip MS and physical function, but the positive effects were not maintained at follow-up. While activities of daily life may become easier as a result of RYGB, the observed extensive post-operative loss of MS requires more attention to increase the patient's physical capacity prospectively., (© 2018 World Obesity Federation.)