The Morbid Obesity Center, Vestfold Hospital Trust
Tønsberg, Vestfold, 3103, Norway
NCT Number: NCT01778738
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tønsberg, Vestfold, 3103, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention
Vertical sleeve gastrectomy
Gastric bypass surgery
Time frame: One year
HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy
Time frame: One Year
Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.
Time frame: Five weeks to five years
HbA1c
Time frame: 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.
Time frame: 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.
Time frame: Five weeks to five years
Use of glucose lowering agents
Time frame: Five weeks to five years
Body weight (kg and kg/m2)
Time frame: Five weeks to five years
Measured by DEXA and bioelectrical impedance analysis
Time frame: Five weeks to five years
Resting and 24-h ambulatory systolic and diastolic blood pressure
Time frame: 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.
Time frame: Five weeks to five years
Cholesterol and triglyceride levels
Time frame: Five weeks to five years
The ApneaLink Plus was used for the calculation of apnoeas and hypopnoeas during sleep.
Time frame: Five weeks to five years
Urine protein-to-creatinine and albumin-to-creatinine ratios
Time frame: One to five years
Gastroesophageal reflux disease will be diagnosed using upper endoscopy, 24 hour intra-oesophageal pH monitoring and symptom scores.
Time frame: One to five years
High-resolution manometry
Time frame: 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.
Time frame: One to five years
Microbial composition and diversity and quantification of organic acids and DNA extraction and metagenome data analysis.
Time frame: Five weeks to five years
Measured and self-reported physical activity
Time frame: Five weeks to five years
Food frequency questionnaire, food tolerance questionnaire, power of food scale and binge eating scale
Time frame: Five weeks to five years
Short Form Quality of Life questionnaire (SF-36) v. 2.0
Time frame: Five weeks to five years
Impact on Weight Questionnaire IWQOL-Lite and Weight-Related Symptom Measure (WRSM)
Time frame: Five weeks to five years
Beck Depression Inventory
Time frame: Five weeks to five years
DEXA scan
Time frame: Five weeks to five years
Arts' questionnaire
Time frame: Five weeks to five years
Vitamin (B1, B9, B12, D) and mineral (calcium, iron) levels in blood.
Sykehuset i Vestfold HF
Other
Glycaemia, Insulin Secretion and Action in Morbidly Obese Subjects With Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study
Acronym: OSEBERG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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