NCT01341028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
Last Updated

April 25, 2011

Status Verified

February 1, 2007

Enrollment Period

2.6 years

First QC Date

April 18, 2011

Last Update Submit

April 21, 2011

Conditions

Morbid Obesity

Keywords

weight lossappetiteghrelinPYYGLP-1insulinlaparoscopicRoux-en-Y gastric bypassgastric fundus resection

Outcome Measures

Primary Outcomes (1)

  • 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

    The outcome was assessed 12 months after the operation

Secondary Outcomes (1)

  • The effects of the resection of the gastric fundus on glucose levels, appetite and weight loss

    At 12 months after the operation

Study Arms (2)

Roux-en-Y gastric bypass (LRYGBP)

ACTIVE COMPARATOR

Twelve subjects underwent laparoscopic Roux-en-Y gastric bypass

Procedure: Roux-en-Y gastric bypass (LRYGBP)

LRYGBP plus gastric fundus resection

EXPERIMENTAL

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

Procedure: LRYGBP+gastric fundus resection

Interventions

Roux-en-Y gastric bypass (LRYGBP)PROCEDURE

Twelve patients underwent laparoscopic Roux-en-Y gastric bypass

Also known as: LRYGBP
Roux-en-Y gastric bypass (LRYGBP)
LRYGBP+gastric fundus resectionPROCEDURE

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

LRYGBP plus gastric fundus resection

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index higher than 40 kg/m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Rio, Achaia, 26500, Greece

Location

MeSH Terms

Conditions

Obesity, MorbidWeight LossInsulin Resistance

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Theodore K Alexandrides

    Professor of Medicine, School of Medicine, University of Patras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 25, 2011

Study Start

May 1, 2007

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

April 25, 2011

Record last verified: 2007-02

Locations

GR(1)