obesity type 2 diabetes mellitus
Conditions
Interventions
Randomisation between the Laparoscopic Roux-en-Y Gastric Bypass (control) and
the Laparoscopic Mini Gastric Bypass (intervention)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >=18 and =35 at the day of the intake on the bariatric ward and
Exclusion criteria
Exclusion criteria: Known genetic basis for insulin resistance or glucose intolerance Type 1 DM Prior Bariatric surgery Patients requiring a concomitant intervention (such as cholecystectomy, ventral hernia repair) Auto-immune gastritis Known presence of gastro-esophageal reflux disease confirmed by endoscopic investigation or the use of proton-pump inhibitor indicated by complaints of gastro-esophageal reflux (i.e. not indicated by polyfarmacia). Known presence of large hiatal hernia requiring concomitant surgical repair Coagulation disorders (PT time > 14 seconds, aPTT ((dependent on laboratory methods) or known presence of bleeding disorders (anamnestic)) Known presence of hemoglobinopathy Uncontrolled hypertension (RR > 150/95 mmHg) Renal insufficiency (creatinine > 150 umol/L) Pregnancy Breastfeeding Alcohol or drug dependency Patients who are considered incapable to fully understand the study and implications of participation in the study, as a consequence of a language barrier, psychiatric disease or mental disabilities, as judged by the surgeon or the coordinating researcher Participation in any other (therapeutic) study that may influence primary or secondary outcomes, Notably, patients that use vitamin K antagonists or non-vitamin K antagonist oral anticoagulants (i.e. NOACs (Factor Xa inhibitors)) and in whom peri-operative bridging with a therapeutic dose of heparin is indicated, will not undergo intra-operative tissue and/or portal vein sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is to assess glycaemic control as measured by the difference in Hba1C at twelve months after LRYGB and LMGB. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycaemic control (as measured by the difference in HBa1c) at 6, 24, 36, 48, 60 months and 10 years after surgery. The remission of T2DM (as determined by use of anti-diabetic medication) at 6, 12, 24, 36, 48, 60 months and 10 years after LRYGB and LMGB. To identify microbial, immunological and metabolic markers for NAFLD/NASH and metabolic response before and after LMGB or LRYGB and to apply systems biology approach to identify hierarchy of driving mechanisms (microbial, immunological and metabolic markers) involved in the long term beneficial effects of LRYGB and LMGB that can be used for personalised medicine. To study the (long-term) effects of bariatric surgery on blood pressure, cardiac output and baroreflex sensitivity. To correlate changes in blood pressure, cardiac output and baroreflex sensitivity to changes in metabolic and other parameters. To determine the relation of NAFLD/NASH and the development of gallstones in relation to gallbladder bile composition and its combined effect on metabolism, T2DM and weight loss after bariatric surgery. To this end, we will collect before, during surgery and up to 10 years follow up: 1. NAFLD/NASH parameters in liver biopsy 2. 2h Mixed meal tolerance test for level of insulin sensitivity and dietary and satiety lists and excreted metabolites (24h faeces and urine as well as BIA and questionnaires) and Electrocardiogram (ECG) at 12 and 24 months; 3. Presence of bacterial DNA/bacterial metabolites in portal vein blood, liver and abdominal adipose tissue depots 4. Small intestinal and faecal microbiota composition and peripheral blood inflammatory markers at 2, and 6 weeks, 6 months, as well as 12, 24, 36, 48,60 months and 10 years after surgery; also oral microbioma at baseline, 12, 24, 36, 48,60 months and 10 years. 5. Expression and differentiation of intestinal immunological cells in GALT (Peyer*s patches), visceral/subcutaneous adipose tissue, liver and peripheral blood (notably ILC*s, m | — |
Countries
Netherlands
Outcome results
None listed