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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014