Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study
- Conditions
- Type 2 DiabetesMorbid Obesity
- Interventions
- Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomyProcedure: Sleeve gastrecomyProcedure: Bastric bypass
- Registration Number
- NCT01778738
- Lead Sponsor
- Sykehuset i Vestfold HF
- Brief Summary
Glycaemia, insulin secretion and action in morbidly obes subjects with type 2 diabetes after sleeve gastrectomy ond Roux-en-Y gastric bypass: A randomised single centre study.
- Detailed Description
The Roux-en-Y gastric bypass operation combines restrictive and malabsorptive principles. It is the most commonly performed bariatric procedure worldwide (\~ 50 %). Vertical (sleeve) gastrectomy on the other hand, is a purely restrictive procedure and has gained popularity and is now accepted as a valid procedure accounting for approximately five percent of the bariatric procedures performed worldwide.
The remission rate of type 2 diabetes one to two years after bariatric surgery is approximately 70%. Some studies have indicate that the remission rate of type 2 diabetes is higher after gastric bypass than after sleeve gastrectomy. Other studies indicate a similar effect on the reduction in HbA1c.
Weight reduction is comparable between gastric bypass and sleeve gastrectomy although some evidence suggets a larger weight loss following gastric bypass surgery. Larger weight loss can clearly contribute to somewhat greater improvement in glucose homeostasis after gastric bypass than after sleeve gastrectomy. Still, one might speculate that changes in gut hormones may contribute to higher remission rates of type 2 diabetes after gastric bypass than after sleeve gastrectomy.
Improved β-cell function observed after gastric bypass surgery may be linked to higher postprandial levels of Glucagonlike peptide 1 as seen after gastric bypass surgery. Beta cell function has, to our knowledge, only been addressed in one previous study after sleeve gastrectomy, with the authors reporting an increased first-phase insulin secretion three days after the procedure. Although several studies have addressed changes in gastrointestinal hormones the incretin effect on insulin secretion after gastric bypass has been estimated in only a few studies. To the best of our knowledge the incretin effect on insulin secretion after sleeve gastrectomy remains unexplored.We are aware of four ongoing randomised controlled trials comparing the effect of gastric bypass and sleeve gastrectomy on several endpoints including weight and comorbidities (ClinicalTrial.gov identifiers: NCT00722995, NCT00356213, NCT00793143, and NCT00667706). However, these studies include both subjects with and with-out type 2 diabetes and are therefore not powered to detect between-group differences in HbA1c and beta-cell function in the diabetic patients.
In conclusion, the effect of gastric bypass and sleeve gastrectomy on glycaemia is not fully elucidated. Moreover, the impact of altered beta-cell function post surgery needs to be explored. We hypothesise that greater improvement in beta-cell function after gastric bypass than after sleeve gastrectomy translates into better glycaemic control in subjects with type 2 diabetes one year after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleeve gastrectomy Sleeve gastrecomy Sleeve gastrectomy. Sleeve gastrectomy Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy Sleeve gastrectomy. Gastric bypass Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy Gastric bypass surgery. Gastric bypass Bastric bypass Gastric bypass surgery.
- Primary Outcome Measures
Name Time Method Remission of type 2 diabetes. One year HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy
Beta-cell function One Year Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.
- Secondary Outcome Measures
Name Time Method Insulin sensitivity Five weeks to five years Fasting and stimulated levels of glucose, insulin and C-peptide after an oral glucose load will be used for the calculation of insulin sensitivity.
Proteinuria Five weeks to five years Urine protein-to-creatinine and albumin-to-creatinine ratios
Glycaemic control Five weeks to five years HbA1c
Bone mineral density Five weeks to five years DEXA scan
Body weight Five weeks to five years Body weight (kg and kg/m2)
Lipidemia Five weeks to five years Cholesterol and triglyceride levels
Obstructive sleep apnoea Five weeks to five years The ApneaLink Plus was used for the calculation of apnoeas and hypopnoeas during sleep.
Fatty liver disease One to five years MRI (Siemens Aera 1.5 T) and Chemical Shift Imaging18 will be used to quantify the fat-fraction content of the liver.
Health related quality of life Five weeks to five years Short Form Quality of Life questionnaire (SF-36) v. 2.0
Obesity-related symptoms Five weeks to five years Impact on Weight Questionnaire IWQOL-Lite and Weight-Related Symptom Measure (WRSM)
Psychological distress Five weeks to five years Beck Depression Inventory
Insulin secretion Five weeks to five years Fasting and stimulated levels of glucose, insulin, C-peptide and proinsulin after an oral glucose load will be used for the calculation of insulin secretion.
Anti-diabetic medication Five weeks to five years Use of glucose lowering agents
Blood pressure Five weeks to five years Resting and 24-h ambulatory systolic and diastolic blood pressure
Pulse wave velocity Five weeks to five years The Sphygmocor system (Artcor, Sidney, Australia) and a single high-fidelity applanation tonometer (Millar®) will be used to measure pulse wave velocity.
Energy intake and eating behaviour Five weeks to five years Food frequency questionnaire, food tolerance questionnaire, power of food scale and binge eating scale
Body composition Five weeks to five years Measured by DEXA and bioelectrical impedance analysis
Gastroesophageal reflux disease One to five years Gastroesophageal reflux disease will be diagnosed using upper endoscopy, 24 hour intra-oesophageal pH monitoring and symptom scores.
Gut microbiota One to five years Microbial composition and diversity and quantification of organic acids and DNA extraction and metagenome data analysis.
Dumping syndrome Five weeks to five years Arts' questionnaire
Gastroesophageal motility disorders One to five years High-resolution manometry
Physical activity Five weeks to five years Measured and self-reported physical activity
Vitamin and mineral deficiencies Five weeks to five years Vitamin (B1, B9, B12, D) and mineral (calcium, iron) levels in blood.
Trial Locations
- Locations (1)
The Morbid Obesity Center, Vestfold Hospital Trust
🇳🇴Tønsberg, Vestfold, Norway