Diabetes Remission After RYGBP and RYGBP With Fundus Resection

• Sponsor: University of Patras (Other)
• Overall Status: Completed
• CT.gov ID: NCT05854875
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 42.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Morbid Obesity; Bariatric Surgery	Procedure: Laparoscopic Roux en Y gastric bypass; Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Sep 22, 2019
• Actual Primary Completion Date: Mar 2, 2023
• Actual Study Completion Date: Apr 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RYGBP Laparoscopic Roux en Y Gastric Bypass	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.
Experimental: RYGBP + FR Laparoscopic Roux en Y Gastric Bypass with fundus resection	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.

Outcome Measures

Primary Outcome Measures

1. Diabetes remission in both groups [At 6 months and 12 months postoperatively]

   Change in HbA1c levels

2. Change in fasting and postprandial glucose levels [At 6 months and 12 months postoperatively]

   Glucose levels (mg/dl)

3. Change in insulin levels, fasting and postprandial [At 6 months and 12 months postoperatively]

   Insulin levels (μIU/ml)

4. Change in HOMA - IR [At 6 months and 12 months postoperatively]

   HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)

5. Change in ghrelin levels [At 6 months and 12 months postoperatively]

   Fasting and postprandial ghrelin levels (pg/ml)

6. Change in GLP-1 levels [At 6 months and 12 months postoperatively]

   Fasting and postprandial GLP-1 levels (pg/ml)

7. Change in PYY levels [At 6 months and 12 months postoperatively]

   Fasting and postprandial PYY levels (ng/ml)

8. Change in glucagon levels [At 6 months and 12 months postoperatively]

   Fasting and postprandial glucagon levels (pg/ml)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Patras, University Hospital of Patras	Patras	Rio	Greece	26504

Sponsors and Collaborators

• University of Patras

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dimitrios Kehagias, Principal Investigator, University of Patras
• ClinicalTrials.gov Identifier: NCT05854875
• Other Study ID Numbers: 5378/35835
• First Posted: May 11, 2023
• Last Update Posted: May 11, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dimitrios Kehagias, Principal Investigator, University of Patras: Gastric Fundus; Gastrointestinal Hormones
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid

Study Results

No Results Posted as of May 11, 2023