Ghrelin Changes After Roux-en-Y Gastric Bypass

• Sponsor: Vanderbilt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00765596
• Collaborator: (none)
• Enrollment: 14
• Location: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Obesity; Insulin Resistance	Other: Liquid diet for 3 days

Study Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• 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?
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Dec 1, 2006

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Ghrelin [pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op]

Secondary Outcome Measures

1. HOMA [pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op]

2. metabolic hormones [pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT00765596
• Other Study ID Numbers: IRB#041129
• First Posted: Oct 3, 2008
• Last Update Posted: Nov 17, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University: Obesity; Insulin resistance; Gastric tube; Ghrelin
• Additional relevant MeSH terms: Insulin Resistance

Study Results

No Results Posted as of Nov 17, 2011