The healthcare costs of increased body mass index-evidence from The Trøndelag Health Study.

BACKGROUND: Earlier studies have estimated the impact of increased body mass index (BMI) on healthcare costs. Various methods have been used to avoid potential biases and inconsistencies. Each of these methods measure different local effects and have different strengths and weaknesses. METHODS: In the current study we estimate the impact of increased BMI on healthcare costs using nine common methods from the literature: multivariable regression analyses (ordinary least squares, generalized linear models, and two-part models), and instrumental variable models (using previously measured BMI, offspring BMI, and three different weighted genetic risk scores as instruments for BMI). We stratified by sex, investigated the implications of confounder adjustment, and modelled both linear and non-linear associations. RESULTS: There was a positive effect of increased BMI in both males and females in each approach. The cost of elevated BMI was higher in models that, to a greater extent, account for endogenous relations. CONCLUSION: The study provides solid evidence that there is an association between BMI and healthcare costs, and demonstrates the importance of triangulation.

The Prevalence of Bradycardia 12 Years After Roux-en-Y Gastric Bypass for Severe Obesity.

PURPOSE: The aim was to describe the frequency of bradycardia 12 years after Roux-en-Y gastric bypass (RYGB), relations to weight loss, patient characteristics, and the clinical impact. MATERIALS AND METHODS: The BAROPS study is a prospective observational study of patients who had follow-up > 10 years after RYGB. Patients with heart rate (HR) ≤ 50 bpm were compared to patients with HR > 50 bpm. RESULTS: After a mean observation period of 12 years, 32 of 546 patients (6%) had a HR ≤ 50 with a mean HR of 47.0 (2.8) bpm. The comparator group (192 patients) had a mean HR of 66.4 (10.2) bpm (p < 0.001). A higher proportion of the bradycardic vs. non-bradycardic patients (18.8% vs. 7.8% at baseline (p = 0.05) and 18.8% vs. 5.2% at end of study (p = 0.006)) used beta-blockers. Both groups had a significant reduction in heart rate from pre-surgery to end of observation. Percent total weight loss from baseline was negatively related to heart rate (p < 0.001), and smoking was positively related to heart rate (p = 0.014). Change in BMI from pre-surgery (p < 0.001) and hypertension at pre-surgery (p = 0.006) were significant predictors of change in heart rate. The only predictor of HR ≤ 50 was the use of beta-blockers (p = 0.010). There were no difference in bradycardia-related symptoms. CONCLUSION: Six percent of patients had HR ≤ 50 bpm 12 years after RYGB, but there was no increased bradycardia-related symptoms in these patients. RYGB induced a significant reduction in HR, and heart rate and changes in heart rate 12 years after RYGB were related to the amount of weight loss.

Postbariatric hypoglycemia, abdominal pain and gastrointestinal symptoms after Roux-en-Y gastric bypass explored by continuous glucose monitoring.

BACKGROUND: Abdominal pain and postbariatric hypoglycemia (PBH) are common after bariatric surgery. OBJECTIVES: This study aimed to explore the potential relationship between abdominal pain, gastrointestinal symptoms, and PBH more than a decade after Roux-en-Y gastric bypass (RYGB) and whether continuous glucose monitoring (CGM) with dietary intervention has an educational role in reducing symptoms. SUBJECTS: At two public hospitals in Norway (one University Hospital) 22 of 46 invited patients who reported abdominal pain more than weekly took part. Recruited from a prospective follow-up study of 546 patients 14.5 years after RYGB. METHODS: They used a CGM for two 14-day periods, with a dietary intervention between periods. The Gastrointestinal Symptom Rating Scale (GSRS) and the Dumping Severity Score (DSS) questionnaires were completed at the start and end of the study. RESULTS: The 22 women had preoperative age 39.6 ± 7.7 years and body mass index (BMI) 42.0 ± 4.0 kg/m2, present age 54.6 ± 7.7 years and BMI 29.8 ± 4.8 kg/m2. The total GSRS score and DSS of early dumping decreased after the diet intervention. The number of events with Level 1 (<3.9 mmol/L) or Level 2 (<3.0 mmol/L) hypoglycemia did not change in the second period. Half of the patients had fewer, three had unchanged, and eight had more frequent events with Level 1 hypoglycemia after the intervention. Ten patients had Level 2 hypoglycemia. CONCLUSION: Though inconclusive findings, a personalized dietary intervention reduces GSRS. This intervention was accompanied by lower mean absolute glucose in patients with recurrent abdominal pain after bariatric surgery. However, further studies are needed to explore the benefits of CGM in this setting.

Suboptimal Weight Loss 13 Years After Roux-en-Y Gastric Bypass Is Associated with Blunted Appetite Response.

PURPOSE: Bariatric surgery remains the most efficient treatment to achieve a sustained weight loss. However, a large proportion of patients experience suboptimal weight loss (SWL). The exact mechanisms involved remain to be fully elucidated, but the homeostatic appetite control system seems to be involved. The aim of this study was, therefore, to compare the plasma concentration of gastrointestinal hormones, and appetite ratings, between those experiencing SWL and optimal weight loss (OWL) after Roux-en-Y gastric bypass (RYGB). MATERIALS AND METHODS: Fifty participants from the Bariatric Surgery Observation Study (BAROBS) experiencing either SWL or OWL (< or ≥ 50% of excess weight loss (EWL), respectively) > 13 years post-RYGB were compared to 25 non-surgical controls. Plasma concentrations of acylated ghrelin (AG), total glucagon-like peptide-1 (GLP-1), total peptide YY (PYY), cholecystokinin (CCK), and subjective ratings of hunger, fullness, desire to eat (DTE), and prospective food consumption (PFC) were assessed in the fasting and postprandial (area under the curve (AUC)) states. RESULTS: Those experiencing OWL presented with higher basal AG and GLP-1 iAUC, and lower AG iAUC compared with SWL and controls. Additionally, both bariatric groups presented with higher PYY and CCK iAUC compared to controls. PFC tAUC was also lower in OWL compared to the SWL group. Total weight loss was positively correlated with GLP-1 tAUC and negatively correlated with fasting and tAUC DTE and PFC tAUC. CONCLUSIONS: SWL > 13 years post-RYGB is associated with lower basal ghrelin, as well as a weaker satiety response to a meal. Future studies should investigate the causality of these associations.

Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol.

INTRODUCTION: Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed.The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity. METHOD AND ANALYSIS: This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to. ETHICS AND DISSEMINATION: The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team. TRIAL REGISTRATION NUMBER: NCT03273855.

Vitamin and Mineral Deficiency 12 Years After Roux-en-Y Gastric Bypass a Cross-Sectional Multicenter Study.

PURPOSE: Micronutrient deficiencies are common after Roux-en-Y gastric bypass (RYGB). This study explores whether vitamin and mineral deficiency was associated with adherence to recommended supplementation 12 years after RYGB. MATERIALS AND METHODS: The cross-sectional Bariatric Surgery Observation Study (BAROBS) was conducted in 2018-2020 at three hospitals in Central Norway. We report data on 490 patients' self-reported adherence to recommended supplements and vitamin and mineral levels in the blood. The patients, who had RYGB between 2003 and 2009, were recommended an over-the-counter multivitamin-mineral supplement, calcium/vitamin D (1000 mg/20 µg) and vitamin B12 injections (reimbursed), since bariatric supplements were not available then. RESULTS: Mean (SD) age was 40.1 ± 9 years at RYGB, and time to follow-up 11.7 ± 1.6 years. Of 490 patients, 393 (80%) were women. Among 361 (74%) patients' adherent to multivitamin-mineral supplements; folate, vitamin B2, and vitamin B6 deficiency were present in 39 (11%), 103 (29%), and 63 (17%) patients, respectively. The same deficiencies occurred in 44 (34%), 67 (52%), and 67 (52%) patients' non-adherent to recommendations. Although 466 (95%) patients reported adherence to vitamin B12 supplements, sub-optimal levels were found in 73 (16%) patients. Though 336 (69%) patients adhered to calcium/vitamin D supplements (1000 mg/20 µg), sub-optimal vitamin D levels (< 75 nmol/l) were found in 174/336 (52%) adherent patients and 120/154 (78%) non-adherent patients. CONCLUSION: Twelve years after RYGB, adherence to supplements, though in sub-optimal doses of new recommendations, decreases the probability of vitamin and mineral deficiency, especially for thiamine, vitamin B2, vitamin B6, folate, vitamin B12, and vitamin D, but does not eliminate it.

How Did People with Prediabetes Who Attended the Diabetes Prevention Education Program (DiPEP) Experience Making Lifestyle Changes? A Qualitative Study in Nepal.

Diabetes can be prevented through lifestyle modification in the prediabetic phase. A group-based lifestyle intervention called 'Diabetes Prevention Education Program' (DiPEP) was tested recently in Nepal. The present study aimed to explore experiences of making lifestyle changes among people with prediabetes participating in the DiPEP. This qualitative study, with semi-structured interviews of 20 participants, was conducted 4-7 months following DiPEP intervention. Data analysis was performed by thematic analysis. The results included four themes, understanding that diabetes could be prevented, lifestyle changes made, hurdles to overcome, and experiencing benefits leading to sustained change. Some participants said they felt relieved to know that they had a chance to prevent diabetes. The participants talked mostly about making changes in diet (reducing carbohydrate intake) and physical activity (starting exercises). Obstacles mentioned included a lack of motivation and a lack of family support to implement changes. Experiencing benefits such as weight loss and reduced blood sugar levels were reported to lead them to maintain the changes they had made. Understanding that diabetes could be prevented was a key motivator for implementing changes. The benefits and hurdles experienced by the participants of the present study can be taken into consideration while designing lifestyle intervention programs in similar settings.

Factors Associated with Medication Adherence among Patients with Type 2 Diabetes Mellitus: A Hospital-Based Cross-Sectional Study in Nepal.

As diabetes increases globally, high mortality increases due to complications of uncontrolled sugar. Medication adherence is important to control blood sugar and prevent its complications. Objective of the study was to identify factors associated with medication adherence among type 2 diabetes patients. A cross-sectional study was conducted among 343 patients visiting Dhulikhel Hospital, Nepal, for their fasting blood sugar test from September to December 2016. Inclusion criteria: patients with type 2 diabetes, under diabetes medication for past three months (minimum), age ≥ 18 years. The outcome of the study was medication adherence measured using the eight-item Morisky medication adherence scale (MMAS-8) (© 2006 Donald E. Morisky). Multivariate logistic regression was used for the analysis. Results showed that 61% of respondents had high medication adherence; adherence was positively associated with formal education [AOR: 2.43 (95% CI: 1.34, 4.39)] and attendance at diabetes counseling [AOR: 1.76 (95% CI: 1.02, 3.04)] after adjusting for age, occupation, medicine intake duration and diabetes medicine types. The study concluded that formal education and attendance at diabetes counseling positively affected patients' adherence to medicine. We encourage healthcare institutions to provide counseling services to all the patients with type 2 diabetes and focus more on those who are less educated.

Frequency of cholelithiasis in need of surgical or endoscopic treatment a decade or more after Roux-en-Y gastric bypass.

BACKGROUND: Symptomatic cholelithiasis requiring treatment is a known side effect after Roux-en-Y gastric bypass (RYGB), but reported rates vary greatly. The objectives for this study were to evaluate the long-term frequency of surgical or endoscopic treatment for symptomatic cholelithiasis 10-15 years after RYGB and its relation to self-reported abdominal pain. METHODS: Observational data from 546 patients who underwent RYGB at public hospitals in Central Norway between March 2003 and December 2009 were analyzed. RESULTS: Median follow-up was 11.5 (range 9.1-16.8) years. Sixty-five (11.9%) patients had undergone cholecystectomy prior to RYGB. Out of the 481 patients with intact gallbladder, 77 (16.0%) patients underwent cholecystectomy and six (1.2%) patients had treatment for choledocholithiasis during the observation period. Median time from RYGB to cholecystectomy or treatment of choledocholithiasis was 51 (range 1-160) and 109 (range 10-151) months, respectively. Female sex was associated with an increased risk of subsequent cholecystectomy [OR (95% CI) 2.88 (1.31-7.15)], p < 0.05. There was a higher frequency of self-reported abdominal pain at follow-up [OR (95% CI) 1.92 (1.25-2.93)] among patients who underwent cholecystectomy before or after RYGB. CONCLUSION: With a median follow-up of more than 11 years after RYGB, one in six patients with an intact gallbladder at time of RYGB underwent cholecystectomy, and 1.1% of the patients needed surgical or endoscopic treatment for choledocholithiasis. Patients with a history of cholecystectomy reported a higher frequency of abdominal pain.

Effectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: a cluster randomised controlled trial in Nepal.

Background: Although several lifestyle intervention studies have been conducted in low/middle-income countries, there were no such studies in Nepal. Therefore, a group-based culturally tailored Diabetes Prevention Education Program (DiPEP) was conducted recently. The study aimed to evaluate the effect of DiPEP in glycated haemoglobin (HbA1c), weight, waist circumference, physical activity and diet among population with pre-diabetes. Method: A two-arm cluster randomised controlled trial was conducted in 12 clusters of two urban areas in Nepal. The DiPEP was a 6 month intervention (four 1-hour weekly educational sessions and 5 months of follow-up by community health workers/volunteers (CHW/Vs)). A postintervention assessment was done after 6 months. Linear mixed model was used to estimate the mean difference in primary outcome (HbA1c) and secondary outcomes (weight, waist circumference, physical activity and diet) between intervention and control arms, adjusted for baseline measure. Results: In intention-to-treat analysis with a total of 291 participants, the estimated mean difference in HbA1c was found to be 0.015 percentage point (95% CI -0.074 to 0.104) between the intervention arm and the control arm, while it was -0.077 (95% CI -0.152 to -0.002) among those who attended at least 3 out of 4 educational sessions. The estimated mean difference in weight (in participants who attended ≥1 educational session) was -1.6 kg (95% CI -3.1 to -0.1). A significantly lower grain consumption was found in intervention arm (-39 g/day, 95% CI -65 to -14) compared with the control arm at postintervention assessment. Conclusion: Although compliance was affected by COVID-19, individuals who participated in ≥3 educational sessions had significant reduction in HbA1c and those who attended ≥1 educational session had significant weight reduction. Grain intake was significantly reduced among the intervention arm than the control arm. Hence, group-based lifestyle intervention programmes involving CHW/vs is recommended for diabetes prevention. Trial registration number: NCT04074148.

Prevalence of prediabetes and associated factors of prediabetic stages: a cross-sectional study among adults in Nepal.

OBJECTIVES: To estimate the prevalence of prediabetes and to assess the association of prediabetic stages with sociodemographic, lifestyle and clinical factors DESIGN: Cross-sectional study at the screening and inclusion stage of a Diabetes Prevention Education Program (DiPEP) trial SETTING: The study was conducted in two urban communities in Nepal (October 2019-March 2020). PARTICIPANTS: A total of 6222 residents of two study sites, aged 18-64 years and without a history of diabetes, were eligible for prediabetes screening. Exclusion criteria were pregnancy, history of diabetes and critical illness. A total of 291 participants with prediabetes were included in this study. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence of prediabetes based on glycated haemoglobin (HbA1c) criteria (5.7%-6.4%) was the primary outcome of the study. Odds Ratio and 95% CI were estimated to assess the associations between the outcome prediabetic stages (5.7%-5.9% vs 6.0%-6.4%) and sociodemographic, lifestyle and clinical factors in both unadjusted and adjusted models. RESULTS: Out of 6222 screened participants, 308 (5%, 95% CI: 4.4% to 5.5%) individuals were detected with prediabetes based on HbA1c. The mean age of 291 responded participants was 50.3±7.6 years and 67% were females. Among them, 78% aged 45-64 years, 97% had central obesity, 90% had high waist-hip ratio, 63% were hypertensive and 66% had no family history of diabetes. Approximately, 54% and 46% of individuals with prediabetes had HbA1c of 5.7%-5.9% and 6.0%-6.4%, respectively. Female gender was associated with prediabetes with HbA1c 6.0%-6.4% (OR, 1.98, 95% CI: 1.07 to 3.67) in the adjusted model. CONCLUSION: The estimated prevalence of prediabetes was 5% among screened participants, and female gender was associated with the prediabetic stage. As a large proportion of the population with prediabetes were not aware of their status, this study demonstrates a need for regular community screening programmes to detect individuals with prediabetes and provide them a comprehensive lifestyle intervention for diabetes prevention. TRIAL REGISTRATION NUMBER: NCT04074148, 2019/783.

The Effect of Roux-en-Y Gastric Bypass on Non-Alcoholic Fatty Liver Disease Fibrosis Assessed by FIB-4 and NFS Scores-An 11.6-Year Follow-Up Study.

Severe obesity is a strong risk factor for non-alcoholic fatty liver disease (NAFLD). Roux-en-Y gastric bypass (RYGB) surgery effectively induces weight loss, but few studies have described the long-term effects of RYGB on NAFLD-related fibrosis. Data from 220 patients with severe obesity operated by RYGB in Central Norway were analysed. Variables incorporated in NAFLD Fibrosis Score (NFS), Fibrosis-4 (FIB-4) index and anthropometric data were collected before surgery and a mean of 11.6 years postoperatively. FIB-4 > 1.3 or NFS > 0.675 were used as cut-off values for advanced fibrosis. Proportions with advanced fibrosis decreased from 24% to 14% assessed by FIB-4 and from 8.6% to 2.3% using NFS, with resolution rates of advanced fibrosis of 42% and 73%, respectively. The shift towards lower fibrosis categories was significant (NFS p < 0.0001; FIB-4 p = 0.002). NFS decreased from −1.32 (IQR −2.33−−0.39) to −1.71 (IQR −2.49−−0.95, p < 0.001) 11.6 years after surgery, whereas FIB-4 did not change: 0.81 (IQR 0.59−1.25) to 0.89 (IQR 0.69−1.16, p = 0.556). There were weak correlations between change in fibrosis scores and weight loss. In conclusion, the majority of patients with advanced fibrosis at baseline had improvement after 11.6 years. Factors associated with reduction in fibrosis were not identified.

The Long-Term Impact of Postoperative Educational Programs on Weight Loss After Roux-en-Y Gastric Bypass.

PURPOSE: Roux-en-Y gastric bypass (RYGB) is a well-documented treatment of severe obesity. Attending postoperative educational programs may improve the outcome. The aim of this study was to evaluate whether participation in educational programs lasting 2-3 years after RYGB influences long-term weight loss, weight regain, physical activity, and compliance to multivitamin supplements. MATERIALS AND METHODS: The Bariatric Surgery Observation Study (BAROBS) is a multicenter retrospective, cross-sectional study 10-15 years after primary RYGB. Four hundred and ninety-seven participants answered questions regarding participation in postoperative educational programs. Participants were divided into frequent attendees (FA) and infrequent attendees (IFA) at the educational programs. RESULTS: Ten to 15 years after surgery, a total weight loss (TWL) of 23.2 ± 11.6% were seen in the FA group vs 19.5 ± 12.6% in the IFA group, p < 0.001. Percent excess weight loss (%EWL) was 55.7 ± 28.9% vs 46.0 ± 31.1%, p < 0.001. Weight regain in percent of maximal weight loss for the FA was 32.1 ± 32.8% vs IFA 38.4 ± 40.0%, p = 0.052. No difference between the groups in compliance to multivitamin and physical activity. CONCLUSION: Participants with frequent participation in group-based educational programs had better weight loss outcomes 10-15 years after RYGB and tended to have less weight regain. There was no difference between the two groups in participants compliance to recommended multivitamin supplements and physical activity.

Suboptimal Weight Loss 13 Years After Roux-en-Y Gastric Bypass: Is Hedonic Hunger, Eating Behaviour and Food Reward to Blame?

PURPOSE: Suboptimal weight loss (SWL) and weight regain (WR) following bariatric surgery are common. The exact reasons for this phenomenon remain to be fully elucidated. To compare hedonic hunger, food preferences, food reward and eating behaviour traits between participants with SWL and optimal weight loss (OWL) 13 years after Roux-en-Y gastric bypass (RYGB). MATERIALS AND METHOD: Cross-sectional case control study where participants experiencing SWL or OWL (< or ≥ 50% of excess weight, respectively) post-RYGB were compared to a non-surgical control group matched for pre-operative body mass index. Hedonic hunger (Power of Food Scale), implicit and explicit liking and wanting for high-fat and low-fat savoury and sweet food (Leeds Food Preference Questionnaire) and eating behaviour (Dutch Eating Behavior Questionnaire, Three-Factor Eating Questionnaire and the Food Cravings Questionnaires State and Trait-reduced) were assessed. RESULTS: In total, 75 participants were recruited from the bariatric surgery observation study (BAROBS). Disinhibition, hunger, emotional, external and restrained eating, frequency of cravings and hedonic hunger were lower in the OWL, compared with the SWL and/or control groups. Implicit wanting and explicit liking and wanting for high-fat savoury and high-fat sweet food were lower, and implicit wanting for low-fat savoury food higher, in the OWL, compared with the SWL and/or control groups. CONCLUSION: SWL 13 years after RYGB is associated with dysfunctional eating behaviours, increased preference and reward for high-fat food and increased hedonic hunger. Future longitudinal studies are needed to establish the cause-effect relationship between these variables.

Preventing type 2 diabetes, overweight and obesity in the Norwegian primary healthcare: a longitudinal design with 60 months follow-up results and a cross-sectional design with comparison of dropouts versus completers.

OBJECTIVES: Studies have demonstrated that it is possible to prevent type 2 diabetes for individuals at high risk, but long-term results in the primary healthcare are limited and high dropout rates have been reported. DESIGN: A longitudinal design was used to study changes in participants' diabetes risk and anthropometrics from baseline to 60 months follow-up. A cross-sectional design was applied to investigate differences between dropouts and completers of the 60 months follow-up. SETTING: Healthy Life Centres in the Norwegian primary healthcare. PARTICIPANTS: 189 individuals aged >18 years with a Finnish Diabetes Risk Score ≥12 and/or a body mass index (BMI) ≥25 kg/m2 were included and offered to attend Healthy Life Centre programmes for 12 months. Measurements were performed annually up to 60 months after inclusion. INTERVENTIONS: Healthy Life Centres arrange behavioural programmes including physical activity offers and dietary courses as part of the primary healthcare. This study offered individuals to attend Healthy Life Centre programmes and followed them for 60 months. PRIMARY OUTCOME: Assess changes in participants' diabetes risk, cardiovascular measures and anthropometrics from baseline to 60 months. SECONDARY OUTCOME: Investigate characteristics of dropouts compared with completers of 60 months follow-up. RESULTS: For participants at 60 months follow-up, diabetes risk and anthropometrics decreased (p<0.001). Out of 65 participants classified as high risk for diabetes at baseline, 27 (42%) changed to being at moderate risk at 60 months follow-up. Remission of diabetes was seen for six of nine participants. Of 189 participants enrolled in the programme, 54 (31%) dropped out at any given point before 60 months follow-up. Dropouts were younger with higher, BMI, weight and waist circumference compared with the completers (p<0.001). CONCLUSIONS: Having a long-term commitment for participants in primary healthcare interventions could be beneficial for the reduction of diabetes risk and improvement of anthropometrics as shown at the 60 months follow-up. TRIAL REGISTRATION NUMBER: NCT01135901.

Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP).

INTRODUCTION: Evidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP. METHODS AND ANALYSES: This is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18-64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140-250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data. ETHICS AND DISSEMINATION: Regional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes. TRIAL REGISTRATION NUMBER: NCT04074148, 2019/783.

Iron Deficiency and Anemia 10 Years After Roux-en-Y Gastric Bypass for Severe Obesity.

Iron deficiency with or without anemia is a well-known long-term complication after Roux-en-Y, gastric bypass (RYGB) as the procedure alters the gastrointestinal absorption of iron. Iron is essential for hemoglobin synthesis and a number of cellular processes in muscles, neurons, and other organs. Ferritin is the best marker of iron status, and in a patient without inflammation, iron deficiency occurs when ferritin levels are below 15 µg/L, while iron insufficiency occurs when ferritin levels are below 50 µg/L. Lifelong regular blood tests are recommended after RYGB, but the clinical relevance of iron deficiency and iron insufficiency might be misjudged as long as the hemoglobin levels are normal. The aim of this study was to explore the frequency of iron deficiency and iron deficiency anemia one decade or more after RYGB, the use of per oral iron supplements, and the frequency of intravenous iron treatment. Nine hundred and thirty patients who underwent RYGB for severe obesity at three public hospitals in Norway in the period 2003-2009 were invited to a follow-up visit 10-15 years later. Results from blood tests and survey data on the use of oral iron supplements and intravenous iron treatment were analyzed. Ferritin and hemoglobin levels more than 10 years after RYGB were available on 530 patients [423 (79.8%) women]. Median (IQR) ferritin was 33 (16-63) µg/L, and mean (SD) hemoglobin was 13.4 (1.3) g/dl. Iron deficiency (ferritin ≤ 15 µg/L) was seen in 125 (23.6%) patients; in addition, iron insufficiency (ferritin 16-50 µg/L) occurred in 233 (44%) patients. Mean (SD) hemoglobin levels were 12.5 (1.4) g/dl in patients with iron deficiency, 13.5 (1.2) g/dl in patients with iron insufficiency, 13.8 (1.3) g/dl in the 111 (21%) patients with ferritin 51-100 µg/L, and 13.8 (1.2) g/dl in the 55 (10%) patients with ferritin >100 µg/L. Two hundred and seventy-five (56%) patients reported taking oral iron supplements, and 138 (27.5%) had received intravenous iron treatment after the RYGB procedure. Iron deficiency or iron insufficiency occurred in two-thirds of the patients 10 years after RYGB, although more than half of them reported taking oral iron supplements.

Characteristics of Patients Reporting Presumed Problematic Drinking Behavior After Gastric Bypass: Exploring Long-Term Data From the BAROBS Study.

Objective: To explore patients' long-term experiences with drinking alcohol after Roux-n-Y gastric bypass (RYGB) for conceptualizing what may indicate problematic drinking behavior after bariatric surgery. Study Design: Three-center, observational study. Patients: 546 adult patients undergoing RYGB in the period 2003-2009 in Norway. Main Outcome Measures: Self-reported data on drinking behavior and experiences related to alcohol collected 10-15 years after surgery. Results: Out of the 959 patients undergoing RYGB in the period, 29 were diseased and 546 participated in this follow-up study (58.7%). Focusing on suspicious changes in drinking behavior, 8.8% reported drinking more, 11.5% consumed alcohol at least twice a week, and 10.6% consumed at a minimum of 6 units of alcohol at a frequency of at least once monthly. The nature of hangovers had changed for about a third of the patients, with 21.6% reporting these to feel weaker or absent. Repeated alcoholic blackouts were reported by 11.9%. A subgroup of the patients were categorized as displaying presumed problematic drinking behavior(PPDB). Among the PPDB-men there was a significant association to having had a fall last year (6 (100.0%) PPDB-patients vs. 30 (29.7%) non-PPDB, p<.001). Among the PPDB-women, there was a significant association to having had alcohol problems prior to surgery (7 (70.0%) PPDB-patients vs. 67 (17.7%) non-PPDB, p<.001). Less significant associations to PPDB reported for explorative purposes were lack of patient education (men) (16 (26.2%) PPDB-patients vs. 8 (61.5%) non-PPDB, p=.014); more than 3 months persistent musculoskeletal pain (women) (45 (15.3%) PPDB-patients vs. 29 (24.6%) non-PPDB, p=.026); subjective problems with memory (women) (58 (20.7%) PPDB-patients vs. 10 (9.1%) non-PPDB, p=.006); and, receiving professional help for mental problems last 12 months (women) (29 (22.7%) PPDB-patients vs. 45 (14.7%) non-PPDB, p=.043). Conclusion: A subset of patients display drinking behaviors that may be consistent with postsurgical alcohol problems. Screening instruments like AUDIT may not be sufficiently specific to capture several risk behaviors occurring after bariatric surgery.

Association between habitual sleep duration/quality and appetite markers in individuals with obesity.

STUDY OBJECTIVES: To assess if habitual sleep duration/quality was associated with appetite in individuals with obesity, and if the association was modulated by sex. METHODS: Sleep duration/quality was measured with Pittsburgh Sleep Quality Index score in 95 healthy adults with obesity (BMI: 36.6 ± 4.2 kg/m2). Subjective feelings of appetite were assessed using visual analogue scales, and plasma concentrations of active ghrelin, total peptide YY, active glucagon-like peptide 1, cholecystokinin (CCK) and insulin were measured in fasting and every 30 min up to 2.5 h after a meal. RESULTS: No significant associations were found between sleep duration, or overall quality, and appetite in all participants. However, a worse sleep efficiency was associated with lower postprandial CCK, a shorter habitual sleep was associated with lower postprandial desire to eat and a lower daytime dysfunction was associated with higher prospective food consumption in fasting (P<0.05, for all). In males, a shorter habitual sleep duration and a worse subjective sleep quality were associated with increased basal and postprandial active ghrelin (P<0.05, P<0.01, P<0.01 and P<0.05, respectively). Also, a shorter habitual sleep was associated with lower basal and postprandial insulin (P<0.05 for both) and a worse overall sleep quality with lower postprandial insulin (P<0.05). In females, a worse overall sleep quality was associated with lower postprandial active ghrelin (P<0.05), and short habitual sleep with higher postprandial insulin (P<0.05). CONCLUSION: A worse habitual sleep efficiency is associated with blunted postprandial CCK secretion in individuals with obesity. The association between habitual sleep duration/quality and insulin and active ghrelin seems to be modulated by sex, but more studies are needed to confirm these findings.