Diabetes Remission After RYGBP and RYGBP With Fundus Resection

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05854875
• Other study ID #: 5378/35835
• Status: Completed
• Phase: N/A
• Start date: September 22, 2019
• Est. completion date: April 10, 2023

Study information

• Verified date: May 2023
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 10, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• morbid obesity (??? = 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Morbid Obesity
• Obesity, Morbid
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	University of Patras, University Hospital of Patras	Patras	Rio

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

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