NCT05854875

Diabetes Remission After RYGBP and RYGBP With Fundus Resection

RYGBP vs RYGBP With Fundus Resection for Morbid Obese Patients With Type 2 Diabetes. Evaluation of the Gastric Fundus in Glycemic Control. A Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes
• Morbid Obesity
• Bariatric Surgery

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Roux en Y gastric bypass	Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.
PROCEDURE	Laparoscopic Roux en Y gastric bypass with fundus resection	Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. Fundus resection is further applied in this arm.

Timeline

• Start date: 2019-09-22
• Primary completion: 2023-03-02
• Completion: 2023-04-10
• First posted: 2023-05-11
• Last updated: 2023-05-11

Locations

1 site across 1 country: Greece