Diabetes Remission After RYGBP and RYGBP With Fundus Resection

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes, Morbid Obesity, Bariatric Surgery

Intervention / Treatment
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* Procedure: Laparoscopic Roux en Y gastric bypass
* Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RYGBP<br>Laparoscopic Roux en Y Gastric Bypass | Procedure: Laparoscopic Roux en Y gastric bypass<br>* Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.<br>|
| Experimental: RYGBP + FR<br>Laparoscopic Roux en Y Gastric Bypass with fundus resection | Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Fundus, Gastrointestinal Hormones