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

Cantonal Hospital of St. Gallen

Status: Completed

Conditions: Bariatric Surgery Candidate; Diabetes Mellitus, Type 2

Treatments: Behavioral: very low caloric diet; Procedure: abdominal surgery; Procedure: gastric bypass surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01271062

EKSG 09/061/2B

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years
• indication forbariatric surgery or non-bariatric abdominal surgery

Exclusion criteria

• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

55 participants in 4 patient groups

T2DM patients before gastric bypass surgery

Active Comparator group

Description:

oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.

Treatment:

Procedure: gastric bypass surgery

Non-diabetic patient before gastric bypass surgery

Active Comparator group

Description:

oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.

Treatment:

Procedure: gastric bypass surgery

non diabetic patients, non-bariatric abdominal surgery

Active Comparator group

Description:

oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.

Treatment:

Procedure: abdominal surgery

severely obese T2DM patients following a very low caloric diet

Active Comparator group

Description:

oral glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet.

Treatment:

Behavioral: very low caloric diet