Early Diabetes Resolution After Weight Loss Surgery - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00790309

Purpose

The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.

Condition	Intervention
Obesity Diabetes	Procedure: Weight loss surgery Procedure: Laparoscopic abdominal surgeries

MedlinePlus related topics: Diabetes Obesity Weight Control Weight Loss Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery

Further study details as provided by Vanderbilt University:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

plasma and serum

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Weight loss surgery This group will be comprised of people having weight loss surgery: Roux-en Y gastric bypass, vertical sleeve gastrectomy, or adjustable gastric banding	Procedure: Weight loss surgery Weight loss surgery
Abdominal surgery This group will be comprised of people having abdominal surgeries such as nissen fundoplication or cholecystectomy.	Procedure: Laparoscopic abdominal surgeries laparoscopic abdominal surgeries

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects scheduled for weight loss surgery or other abdominal surgeries will be considered for the study.

Criteria

Inclusion Criteria:

BMI of 35kg/m2 or higher
Ages 18-65
History of impaired glucose tolerance or T2DM

Exclusion Criteria:

Development of an intercurrent infection
Prior gastric, duodenal, proximal jejunal surgery or pancreas resection
Current use of thiazolidinediones
Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exanatide)
Any condition felt by the PI or co-investigators to interfere with ability to complete the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790309

Contacts

Contact: Pamela A Marks, MS, RD	615-343-8389	pamela.a.marks@vanderbilt.edu
Contact: Marcy Buckley, RN	615-343-2243	obesityresearch@vanderbilt.edu

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Naji Abumrad, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( Naji Abumrad, MD )
Study ID Numbers:	NNA-Early DM Resolution
Study First Received:	November 11, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00790309
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Obesity
Diabetes
Bariatric surgery

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009