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Early Diabetes Resolution After Weight Loss Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00790309
First received: November 11, 2008
Last updated: May 16, 2013
Last verified: May 2013
  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

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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery [ Time Frame: 10 days post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine changes in inflammatory markers after weight loss surgery [ Time Frame: 10 days post-op ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma and serum


Estimated Enrollment: 60
Study Start Date: December 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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., exenatide)
  • Any condition felt by the PI or co-investigators to interfere with ability to complete the study
  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: NCT00790309

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Naji Abumrad, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00790309     History of Changes
Other Study ID Numbers: NNA-Early DM Resolution
Study First Received: November 11, 2008
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Obesity
Diabetes
Bariatric surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Weight Loss
Body Weight
Body Weight Changes
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014