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Completed

NCT Number: NCT05854875

Diabetes Remission After RYGBP and RYGBP With Fundus Resection

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.

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Key information

Conditions

Type 2 Diabetes Bariatric Surgery Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Patras, University Hospital of Patras

Pátrai, Rio, 26504, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Roux en Y gastric bypass

Procedure

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

Procedure

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.

Primary outcomes

  1. Diabetes remission in both groups

    Time frame: At 6 months and 12 months postoperatively

    Change in HbA1c levels

  2. Change in fasting and postprandial glucose levels

    Time frame: At 6 months and 12 months postoperatively

    Glucose levels (mg/dl)

  3. Change in insulin levels, fasting and postprandial

    Time frame: At 6 months and 12 months postoperatively

    Insulin levels (μIU/ml)

  4. Change in HOMA - IR

    Time frame: At 6 months and 12 months postoperatively

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

  5. Change in ghrelin levels

    Time frame: At 6 months and 12 months postoperatively

    Fasting and postprandial ghrelin levels (pg/ml)

  6. Change in GLP-1 levels

    Time frame: At 6 months and 12 months postoperatively

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

  7. Change in PYY levels

    Time frame: At 6 months and 12 months postoperatively

    Fasting and postprandial PYY levels (ng/ml)

  8. Change in glucagon levels

    Time frame: At 6 months and 12 months postoperatively

    Fasting and postprandial glucagon levels (pg/ml)

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 11, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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