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
  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:


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):
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 April 15, 2014