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Gut Hormones After Roux-en-Y Gastric Bypass (RYGBP) Plus Gastric Fundus Resection

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Roux-en-Y gastric bypass (LRYGBP)
LRYGBP+gastric fundus resection
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morbid Obesity focused on measuring weight loss, appetite, ghrelin, PYY, GLP-1, insulin, laparoscopic, Roux-en-Y gastric bypass, gastric fundus resection

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index higher than 40 kg/m2

Exclusion Criteria:

  • pregnancy
  • diabetes mellitus
  • substance abuse
  • chronic medical or psychiatric illness
  • previous gastrointestinal surgery

Sites / Locations

  • University Hospital of Patras

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Roux-en-Y gastric bypass (LRYGBP)

LRYGBP plus gastric fundus resection

Arm Description

Twelve subjects underwent laparoscopic Roux-en-Y gastric bypass

Twelve patients underwent laparoscopic Roux-en-Y gastric bypass plus gastric fundus resection

Outcomes

Primary Outcome Measures

The effects of the resection of the gastric fundus on the secretion of ghrelin, PYY, GLP-1 and insulin.
The effect on the secretion of ghrelin, PYY, GLP-1 and insulin

Secondary Outcome Measures

The effects of the resection of the gastric fundus on glucose levels, appetite and weight loss
The effect of fundus resection on glucose levels, appetite and weight loss was assessed 12 months after the operation

Full Information

First Posted
April 18, 2011
Last Updated
April 21, 2011
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT01341028
Brief Title
Gut Hormones After Roux-en-Y Gastric Bypass (RYGBP) Plus Gastric Fundus Resection
Official Title
Effects of the Resection of the Gastric Fundus on the Secretion of Ghrelin, Peptide-YY, Glucagon-like Peptide-1 and Insulin Secretion in Morbidly Obese Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of restriction-malabsorption procedure and one of the most common operative procedures implemented. Over the last years increasing evidence suggests that the beneficial effects of bariatric operations might be related to the suppression of appetite caused by the release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food intake. In the present study the investigators sought to evaluate the effects of the resection of the gastric fundus, the main source of ghrelin production, on the secretion of ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.
Detailed Description
Twenty four patients were included prospectively in the study. After randomization, 12 patients underwent LRYGBP and 12 LRYGBP plus gastric fundus resection (LRYGBP+FR). All human studies were performed according to the principles of the Declaration of Helsinki. The local Research and Ethics Commitee at the University Hospital of Patras approved the study. Written informed consent was obtained from all patients. All the operations were performed by the same surgeon laparoscopically. The RYGBP procedures were performed creating a small isolated lesser curve-based gastric pouch (20 ± 5 ml) and a 150cm Roux limb. The gastroenteroanastomosis was conducted with a 25 mm circular stapler. The dissection of the fundus of the stomach in the (LRYGBP+FR) group was done with the use of EndoGia No 60. The subjects were studied before and at 3, 6 and 12 months after the operation. All the patients underwent an oral glucose tolerance test (OGTT) with 75 g glucose, preoperatively. In addition, venous blood was collected after an overnight 12 hour fast and 30, 60 and 120 min after the administration of a 300 kcal mixed meal.The meal was consumed in ten minutes and consisted of 18% protein, 55% carbohydrate and 27% fat (Resource energy drink, Nestle Nutrition, France). Plasma levels of PYY, GLP-1, ghrelin and insulin were determined at every time point of the study. All patients underwent complete clinical evaluation during follow-up including nutritional, behavioral and anthropometric parameters. Visual analogue scales (VAS) were used to measure hunger, nausea, fullness and aversion to food, before and 30, 60 and 120 min after the consumption of the meal. Weight loss evaluation was based on postope¬rative body weight, body mass index (BMI) and % excess weight loss (EWL %). Insulin resistance was approximated using the homeostatic model assessment for insulin resistance (HOMA IR). The following formula was used in its calculation: HOMA IR = (fasting glucose [mmole] /lt X fasting insulin [μU/ml])/22.5). The insulinogenic index, a commonly used indicator of pancreatic β-cell function, was calculated as the ratio of increment of insulin concentrations to that of glucose concentrations at 30 minutes after meal ingestion (Δ [ins30 - ins0] / Δ [Glu30 -Glu0]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
weight loss, appetite, ghrelin, PYY, GLP-1, insulin, laparoscopic, Roux-en-Y gastric bypass, gastric fundus resection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roux-en-Y gastric bypass (LRYGBP)
Arm Type
Active Comparator
Arm Description
Twelve subjects underwent laparoscopic Roux-en-Y gastric bypass
Arm Title
LRYGBP plus gastric fundus resection
Arm Type
Experimental
Arm Description
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass plus gastric fundus resection
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass (LRYGBP)
Other Intervention Name(s)
LRYGBP
Intervention Description
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass
Intervention Type
Procedure
Intervention Name(s)
LRYGBP+gastric fundus resection
Intervention Description
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass and gastric fundus resection
Primary Outcome Measure Information:
Title
The effects of the resection of the gastric fundus on the secretion of ghrelin, PYY, GLP-1 and insulin.
Description
The effect on the secretion of ghrelin, PYY, GLP-1 and insulin
Time Frame
The outcome was assessed 12 months after the operation
Secondary Outcome Measure Information:
Title
The effects of the resection of the gastric fundus on glucose levels, appetite and weight loss
Description
The effect of fundus resection on glucose levels, appetite and weight loss was assessed 12 months after the operation
Time Frame
At 12 months after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index higher than 40 kg/m2 Exclusion Criteria: pregnancy diabetes mellitus substance abuse chronic medical or psychiatric illness previous gastrointestinal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore K Alexandrides
Organizational Affiliation
Professor of Medicine, School of Medicine, University of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Patras
City
Rion
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece

12. IPD Sharing Statement

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Gut Hormones After Roux-en-Y Gastric Bypass (RYGBP) Plus Gastric Fundus Resection

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