Ghrelin Changes After Roux-en-Y Gastric Bypass

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Naji Abumrad, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00765596

First received: October 2, 2008

Last updated: November 15, 2011

Last verified: November 2011

History of Changes

Purpose

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.

Condition	Intervention
Obesity Insulin Resistance	Other: Liquid diet for 3 days

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Ghrelin Changes After Roux-en-Y Gastric Bypass: Does Gastric Pouch vs. Gastric Remnant Feeding Affect Secretion?

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Ghrelin [ Time Frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HOMA [ Time Frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op ] [ Designated as safety issue: No ]
metabolic hormones [ Time Frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

plasma, tissues

Enrollment:	14
Study Start Date:	January 2005
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765596

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hansen EN, Tamboli RA, Isbell JM, Saliba J, Dunn JP, Marks-Shulman PA, Abumrad NN. Role of the foregut in the early improvement in glucose tolerance and insulin sensitivity following Roux-en-Y gastric bypass surgery. Am J Physiol Gastrointest Liver Physiol. 2011 May;300(5):G795-802. Epub 2011 Mar 3.

Isbell JM, Tamboli RA, Hansen EN, Saliba J, Dunn JP, Phillips SE, Marks-Shulman PA, Abumrad NN. The importance of caloric restriction in the early improvements in insulin sensitivity after Roux-en-Y gastric bypass surgery. Diabetes Care. 2010 Jul;33(7):1438-42. Epub 2010 Apr 5.

Responsible Party:	Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00765596 History of Changes
Other Study ID Numbers:	IRB#041129
Study First Received:	October 2, 2008
Last Updated:	November 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Obesity
Insulin resistance
Gastric tube
Ghrelin

Additional relevant MeSH terms:

Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013

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