Ghrelin Changes After Roux-en-Y Gastric Bypass

November 15, 2011 updated by: Naji Abumrad, Vanderbilt University

Ghrelin Changes After Roux-en-Y Gastric Bypass: Does Gastric Pouch vs. Gastric Remnant Feeding Affect Secretion?

The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects were morbidly obese, scheduled for RYGB with gastric tube placement. Controls were matched to subjects by BMI, age, gender.

Description

Inclusion Criteria:

  • Serum creatinine and liver function tests < upper limits of normal
  • Stable body weights for the past three months
  • Women will have a negative pregnancy test
  • patients who are already scheduled for RYGB with gastrostomy tube placement

Exclusion Criteria:

  • Significant hepatic enzyme elevations (more than 100% of upper limits of normal)
  • Serum creatinine > 1.5 mg/dl
  • history of ketoacidosis or current metabolic acidosis
  • current use of oral anticoagulants
  • Positive pregnancy test (beta-human chorionic gonadotrophin) for females
  • intercurrent infections
  • patients with prior gastric operations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 RYGB
Subjects undergoing RYGB with gastric tube placement
2 Matched controls
Subjects matched by BMI, age, gender to RYGB group
Other: Liquid diet for 3 days
The control group were given a 3 -day liquid diet similar to the RYGB post-op diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ghrelin
Time Frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op

Secondary Outcome Measures

Outcome Measure
Time Frame
HOMA
Time Frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
metabolic hormones
Time Frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Naji N Abumrad, MD, Department of Surgery, Vanderbilt University Medical Center
  • Principal Investigator: Erik N Hansen, MD, Departement of Surgery, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#041129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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