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.

Enhancing knowledge and coordination in obesity treatment: a case study of an innovative educational program.

BACKGROUND: Currently, there is a lack of knowledge, organisation and structure in modern health care systems to counter the global trend of obesity, which has become a major risk factor for noncommunicable diseases. Obesity increases the risk of diabetes, cardiovascular diseases, musculoskeletal disorders and cancer. There is a need to strengthen integrated care between primary and secondary health care and to enhance care delivery suited for patients with complex, long-term problems such as obesity. This study aimed to explore how an educational program for General Practitioners (GPs) can contribute to increased knowledge and improved coordination between primary and secondary care in obesity treatment, and reports on these impacts as perceived by the informants. METHODS: In 2010, an educational program for the specialist training of GPs was launched at three hospitals in Central Norway opting for improved care delivery for patients with obesity. In contrast to the usual programs, this educational program was tailored to the needs of GPs by offering practice and training with a large number of patients with obesity and type 2 diabetes for an extended period of time. In order to investigate the outcomes of the program, a qualitative design was applied involving interviews with 13 GPs, head physicians and staff at the hospitals and in one municipality. RESULTS: Through the program, participants strengthened care delivery by building knowledge and competence. They developed relations between primary and secondary care providers and established shared understanding and practices. The program also demonstrated improvement opportunities, especially concerning the involvement of municipalities. CONCLUSIONS: The educational program promoted integrated care between primary and secondary care by establishing formal and informal relations, by improving service delivery through increased competence and by fostering shared understanding and practices between care levels. The educational program illustrates the combination of advanced high-quality training with the development of integrated care.

Timeline of changes in adaptive physiological responses, at the level of energy expenditure, with progressive weight loss.

Diet-induced weight loss (WL) is associated with reduced resting and non-resting energy expenditure (EE), driven not only by changes in body composition but also potentially by adaptive thermogenesis (AT). When exactly this happens, during progressive WL, remains unknown. The aim of this study was to determine the timeline of changes in RMR and exercise-induced EE (EIEE), stemming from changes in body composition v. the presence of AT, during WL with a very-low-energy diet (VLED). In all, thirty-one adults (eighteen men) with obesity (BMI: 37 (sem 4·5) kg/m2; age: 43 (sem 10) years) underwent 8 weeks of a VLED, followed by 4 weeks of weight maintenance. Body weight and composition, RMR, net EIEE (10, 25 and 50 W) and AT (for RMR (ATRMR) and EIEE (ATEIEE)) were measured at baseline, day 3 (2 (sem 1) % WL), after 5 and 10 % WL and at weeks 9 (16 (sem 2) %) and 13 (16 (sem 1) %). RMR and fat mass were significantly reduced for the first time at 5 % WL (12 (sem 8) d) (P<0·01 and P<0·001, respectively) and EIEE at 10 % WL (32 (sem 8) d), for all levels of power (P<0·05), and sustained up to week 13. ATRMR was transiently present at 10 % WL (-460 (sem 690) kJ/d, P<0·01). A fall in RMR should be anticipated at ≥5 % WL and a reduction in EIEE at ≥10 % WL. Transient ATRMR can be expected at 10 % WL. These physiological adaptations may make progressive WL difficult and will probably contribute to relapse.

Steady-state energy balance in animal models of obesity and weight loss.

OBJECTIVE: We wanted to exam the steady-state energy balance by using high-fat diet-induced obese (DIO) rats and mice as models for positive energy balance, and gastric bypassed (GB) rats and gene knockout of muscarinic acetylcholine M3 receptor (M3KO) mice as models for negative energy balance. METHODS: One hundred and thirty-two rats and mice were used. Energy balance was measured by a comprehensive laboratory animal monitoring system. Gene expression was analysed by in situ hybridisation in M3KO mice. RESULTS: DIO rats reached the plateau of body weight 28 weeks after starting high-fat diet (25% heavier than controls), whereas DIO mice reached the plateau after 6 weeks (23% heavier than controls). At the plateau, DIO rats had higher calorie intake during the light phase but not during the dark phase, while mice had the same calorie intake per day as controls. DIO rats and mice had lower energy expenditure (EE) and respiratory exchange ratio (RER) than controls. GB-rats reached the plateau (15% weight loss) 2 weeks after surgery and had the same calorie intake as sham-operated controls. EE, but not RER, was higher in GB rats than controls during the dark phase. The lean M3KO mice (25% lighter than wild-type (WT) mice at the plateau between 6 and 15 months of age) had the same calorie intake but higher EE, RER and hypothalamic mRNA expression of NPY, AgRP and leptin receptor than WT mice. CONCLUSION: When body weight gain or loss reached a plateau, the steady-state energy balance was mainly maintained by EE and/or RER rather than calorie intake.

Sleeve gastrectomy, but not duodenojejunostomy, preserves total beta-cell mass in Goto-Kakizaki rats evaluated by three-dimensional optical projection tomography.

BACKGROUND: In type 2 diabetes mellitus, there is a progressive loss of beta-cell mass. Bariatric surgery has in recent investigations showed promising results in terms of diabetes remission, but little is established regarding the effect of surgery on the survival or regeneration of pancreatic beta-cells. In this study, we aim to explore how bariatric surgery with its subsequent hormonal alterations affects the islets of Langerhans. METHODS: Twenty-four Goto-Kakizaki rats were operated with duodenojejunostomy (DJ), sleeve gastrectomy (SG) or sham operation. From the 38th week after surgery, body weight, fasting blood glucose, glycosylated hemoglobin, mixed meal tolerance with repeated measures of insulin, glucagon-like peptide 1, gastrin and total ghrelin were evaluated. Forty-six weeks after surgery, the animals were euthanized and the total beta-cell mass in all animals was examined by three-dimensional volume quantification by optical projection tomography based on the signal from insulin-specific antibody staining. RESULTS: Body weight did not differ between groups (P(g) = 0.37). SG showed lower fasting blood glucose compared to DJ and sham (P(g) = 0.037); HbA1c levels in SG were lower compared to DJ only (p < 0.05). GLP-1 levels were elevated for DJ compared to SG and sham (P(g) = 0.001), whereas gastrin levels were higher in SG compared to the two other groups (P(g) = 0.002). Beta-cell mass was significantly greater in animals operated with SG compared to both DJ and sham (p = 0.036). CONCLUSION: Sleeve gastrectomy is superior to duodenojejunostomy and sham operation when comparing the preservation of beta-cell mass 46 weeks after surgery in Goto-Kakizaki rats. This could be related to both the increased gastrin levels and the long-term improvement in glycemic parameters observed after this procedure.

Exploring lifestyle and risk in preventing type 2 diabetes-a nested qualitative study of older participants in a lifestyle intervention program (VEND-RISK).

BACKGROUND: Lifestyle intervention may reduce the development of type 2 diabetes among high-risk individuals. The aim of this study was to explore how older adults perceived their own lifestyle and being at increased risk for type 2 diabetes while they participated in a lifestyle intervention programme. METHODS: A nested qualitative study was performed with 26 participants (mean age 68 years) in the VEND-RISK Study. Participants had previously participated in the HUNT3 Study and the HUNT DE-PLAN Study, where their risk for developing type 2 diabetes (FIND-RISC ≥ 15) had been identified. The data were analysed using systematic text condensation. RESULTS: Two main themes were identified. The first theme was having resources available for an active lifestyle, which included having a family and being part of a social network, having a positive attitude toward life, and maintaining established habits from childhood to the present. The second theme was being at increased risk for type 2 diabetes, which included varied reactions to the information on increased risk, how lifestyle intervention raised awareness about risk behaviour, and health-related worries and ambitions as type 2 diabetes prevention. CONCLUSIONS: Assessing a participant's resources could improve the outcomes of lifestyle intervention programmes. Both family history and risk perception could be used in preventive strategies to enhance changes in lifestyle. TRIAL REGISTRATION: The VEND-RISK Study was registered in ClinicalTrials.gov on April 26, 2010, with the registration number NCT01135901 .

High-Intensity Interval Training and Isocaloric Moderate-Intensity Continuous Training Result in Similar Improvements in Body Composition and Fitness in Obese Individuals.

This study aimed to determine the effects of 12 weeks of isocaloric programs of high-intensity intermittent training (HIIT) or moderate-intensity continuous training (MICT) or a short-duration HIIT (1/2HIIT) inducing only half the energy deficit on a cycle ergometer, on body weight and composition, cardiovascular fitness, resting metabolism rate (RMR), respiratory exchange ratio (RER), nonexercise physical activity (PA) levels and fasting and postprandial insulin response in sedentary obese individuals. Forty-six sedentary obese individuals (30 women), with a mean BMI of 33.3 ± 2.9 kg/m2 and a mean age of 34.4 ± 8.8 years were randomly assigned to one of the three training groups: HIIT (n = 16), MICT (n = 14) or 1/2HIIT (n = 16) and exercise was performed 3 times/week for 12 weeks. Overall, there was a significant reduction in body weight, waist (p < .001) and hip (p < .01) circumference,, trunk and leg fat mass (FM; p < .01) and an increase in trunk and leg fat free mass (FFM; p < .01) and cardiovascular fitness (VO2max in ml/kg/min; p < .001) with exercise. However, no significant differences were observed between groups. There was no significant change in RMR, RER, nonexercise PA levels, fasting insulin or insulin sensitivity with exercise or between groups. There was a tendency for a reduction in AUC insulin with exercise (p = .069), but no differences between groups. These results indicate that isocaloric training protocols of HIIT or MICT (or 1/2HIIT inducing only half the energy deficit) exert similar metabolic and cardiovascular improvements in sedentary obese individuals.

The effect of duodenojejunostomy and sleeve gastrectomy on type 2 diabetes mellitus and gastrin secretion in Goto-Kakizaki rats.

BACKGROUND: Bariatric surgery is a highly effective treatment of type 2 diabetes in patients with morbid obesity. The weight-loss independent improvement of glycemic control observed after these procedures has led to the discussion whether bariatric surgery can be introduced as treatment for type 2 diabetes in patients with a body mass index < 35 kg/m(2). We have studied the effects of two bariatric procedures on type 2 diabetes and on gastrointestinal hormone secretion in a lean diabetic animal model. METHODS: Male Goto-Kakizaki rats, 17-18 weeks old, were randomized into three groups: duodenojejunostomy (DJ), sleeve gastrectomy (SG), or sham operation. During 36 postoperative weeks we evaluated body weight, fasting blood glucose, glucose tolerance, insulin, HbA1c, glucagon-like peptide 1, cholesterol parameters, triglycerides, total ghrelin, and gastrin. RESULTS: Oral glucose tolerance was significantly improved for both DJ and SG at four weeks after surgery (p < 0.05). At the 34th postoperative week, SG had significantly lower area under the curve during oral glucose tolerance test compared to sham (p = 0.007). SG had significantly lower HbA1c compared to sham at 12 weeks; (mean ± SEM) 4.3 ± 0.1 % versus 5.2 ± 0.3 % (p < 0.05) and compared to both DJ and sham 34 weeks after surgery [median (75 %;25 %)] 5.2 (6.0; 4.3) % versus 7.0 (7.5; 6.7) % and 7.3 (7.6; 6.7) % (p = 0.009). Serum gastrin levels were markedly elevated for SG compared to DJ and sham; 188.0 (318.0; 121.0) versus 77.5 (114.0; 58.0) and 68.0 (90.0; 59.5) pmol/L (p = 0.004) at six weeks and 192.0 (587.8; 110.8) versus 65.5 (77.0; 59.0) and 69.5 (113.0; 55.5) (p = 0.001) 36 weeks after surgery. CONCLUSION: Sleeve gastrectomy induces hypergastrinemia, lowers HbA1c, and improves glycemic control in Goto-Kakizaki rats. Sleeve gastrectomy is superior to duodenojejunostomy as treatment of type 2 diabetes mellitus in this animal model.

Obese, fat, or just overweight?

BACKGROUND: Discussing obesity with the patient without this being perceived as offensive may represent a challenge. Prevention of lifestyle diseases requires that this topic be addressed with those concerned. In this study, we investigate the patients' sensitivity to expressions, i.e. their notions of appropriateness or inappropriateness regarding various terms for obesity, and what patient characteristics are associated with such sensitivity to expressions. MATERIAL AND METHOD: The investigation is part of a five-year study of patients in Central Norway who were treated for morbid obesity. The terms used in the study had been suggested by the Overweight Patients' Association. Data on sensitivity to expressions were collected with the aid of a questionnaire one year after completion of the treatment. RESULTS: Altogether 157 out of 206 participants completed the questionnaire. Their average body mass index (BMI) (SD) amounted to 37.6 kg/m² (7.3 kg/m²). Their sensitivity to 14 different designations varied. «Weight¼, «overweight¼ and «weight problem¼ returned the best scores, whereas «obesitas¼, «obese¼ and «fat¼ were deemed least appropriate. The highest sensitivity to expressions was found among women, those who developed overweight early in life, those who had higher education and those who were dissatisfied with their weight. INTERPRETATION: The perceptions of various expressions for overweight and obesity varied considerably. Knowledge about this topic may be relevant for doctors and other health personnel in prevention and treatment of obesity.

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.

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.

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.

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.

Ex Vivo Demonstration of a Novel Dual-Frequency Ultrasound Method for Quantitative Measurements of Liver Fat Content.

OBJECTIVE: The rise in metabolic dysfunction-associated steatotic liver disease prevalence, closely linked with metabolic syndromes and obesity, demands accurate, cost-effective diagnostic methods for early-stage fat quantification in the liver. Here we demonstrate a novel dual-frequency ultrasound method that enables the quantitative measurement of liver fat fraction ex vivo and its correlation with actual fat content. METHODS: A total of 24 Wistar rats were divided into four different groups, where three groups were given a high-fat diet for 2, 4, and 6 wk, and the last group was given a control diet for 6 wk. Livers were imaged with ultrasound ex vivo in a water bath with a dual-frequency ultrasound transducer and experimental imaging protocol implemented on the Verasonics Vantage research ultrasound scanner. Ultrasound data were post-processed to estimate the non-linear bulk elasticity parameter and the liver samples were analyzed with respect to fat fraction and triglycerides. RESULTS: Rats given a high-fat diet had increased mean levels of liver fat compared with the control group. More importantly, correlation between the ultrasound-based estimation of the non-linear bulk elasticity parameter and fat fraction and triglycerides on an individual level was found to be strong (R2 = 0.81, p = 5.8 × 10-9 and R2 = 0.72, p = 3.6 × 10-7, respectively). CONCLUSION: This study demonstrates the potential of the novel dual-frequency ultrasound method for the quantitative measurement of liver fat fraction in excised rat livers, showing great promise for this method to become clinically relevant in the diagnosis and follow-up of patients with fatty liver disease.

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.

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.

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.

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.

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.