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Ghrelin Changes After Roux-en-Y Gastric Bypass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765596
First Posted: October 3, 2008
Last Update Posted: November 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University
  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?

Further study details as provided by Naji Abumrad, 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 ]

Secondary Outcome Measures:
  • HOMA [ Time Frame: 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 2, 2008
First Posted: October 3, 2008
Last Update Posted: November 17, 2011
Last Verified: November 2011

Keywords provided by Naji Abumrad, Vanderbilt University:
Obesity
Insulin resistance
Gastric tube
Ghrelin

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases