Diabetes Remission After RYGBP and RYGBP With Fundus Resection

University of Patras

Status: Completed

Conditions: Bariatric Surgery; Morbid Obesity; Type 2 Diabetes

Treatments: Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection; Procedure: Laparoscopic Roux en Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT05854875

5378/35835

Details and patient eligibility

About

The goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with fundus resection. The main questions to answer are:

• Rate of diabetes remission and the role of the gastrointestinal hormones
• Whether fundus resection leads to improved glycemic control

Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile [ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• morbid obesity (ΒΜΙ ≥ 40)
• type II diabetes mellitus (T2DM)
• duration of T2DM shorter than 8 years

Exclusion criteria

• pregnancy
• type 1 diabetes
• previous gastrointestinal surgeries
• alcohol consumption
• depression
• no compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

RYGBP

Active Comparator group

Description:

Laparoscopic Roux en Y Gastric Bypass

Treatment:

Procedure: Laparoscopic Roux en Y gastric bypass

RYGBP + FR

Experimental group

Description:

Laparoscopic Roux en Y Gastric Bypass with fundus resection

Treatment:

Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection