Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery

Study Overview
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Brief Summary
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Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of improvement of pathological beta cell function. The presented double-centre study aims to comprehensively investigate different aspects of beta cell function in patients with type 2 diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our project will address the aspects of changes in enteroinsular and adipoinsular axes as well as the early and late changes of other defined parameters after gastric bypass surgery.

Official Title
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Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery in Severely Obese Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: gastric bypass surgery
* Procedure: abdominal surgery
* Behavioral: very low caloric diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years indication forbariatric surgery or non-bariatric abdominal surgery Exclusion Criteria: Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T2DM patients before gastric bypass surgery<br>oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery. | Procedure: gastric bypass surgery<br> <br> |
| Active Comparator: Non-diabetic patient before gastric bypass surgery<br>oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery. | Procedure: gastric bypass surgery<br> <br> |
| Active Comparator: non diabetic patients, non-bariatric abdominal surgery<br>oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery. | Procedure: abdominal surgery<br> <br> |
| Active Comparator: severely obese T2DM patients following a very low caloric diet<br>oral glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet. | Behavioral: very low caloric diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function |  | 10 days after gastric bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OGTT calculations and modelling describing beta cell response to oral glucose load; Insulin and C-peptide areas under the curve (AUCs) during OGTT quantifying the incretin effect. |  | 10 days after gastric bypass | 
| • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis |  | 10 days after gastric bypass | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resolvment of Diabetes Mellitus, Type 2, gastric bypass