Diabetes Remission After RYGBP and RYGBP With Fundus Resection

Not Applicable

Completed

• Conditions: Bariatric Surgery; Type 2 Diabetes; Morbid Obesity
• Interventions: Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection; Procedure: Laparoscopic Roux en Y gastric bypass

• Registration Number: NCT05854875
• Lead Sponsor: University of Patras

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-22
• Primary Completion: 2023-03-02
• Study Completion: 2023-04-10
• Study First Submitted: 2023-04-21
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGBP + FR	Laparoscopic Roux en Y gastric bypass with fundus resection	Laparoscopic Roux en Y Gastric Bypass with fundus resection
RYGBP	Laparoscopic Roux en Y gastric bypass	Laparoscopic Roux en Y Gastric Bypass

Primary Outcome Measures

Name	Time	Method
Diabetes remission in both groups	At 6 months and 12 months postoperatively	Change in HbA1c levels
Change in fasting and postprandial glucose levels	At 6 months and 12 months postoperatively	Glucose levels (mg/dl)
Change in glucagon levels	At 6 months and 12 months postoperatively	Fasting and postprandial glucagon levels (pg/ml)
Change in insulin levels, fasting and postprandial	At 6 months and 12 months postoperatively	Insulin levels (μIU/ml)
Change in HOMA - IR	At 6 months and 12 months postoperatively	HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)
Change in ghrelin levels	At 6 months and 12 months postoperatively	Fasting and postprandial ghrelin levels (pg/ml)
Change in GLP-1 levels	At 6 months and 12 months postoperatively	Fasting and postprandial GLP-1 levels (pg/ml)
Change in PYY levels	At 6 months and 12 months postoperatively	Fasting and postprandial PYY levels (ng/ml)

Trial Locations

Locations (1)

University of Patras, University Hospital of Patras; 🇬🇷 Patras, Rio, Greece