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Early Diabetes Resolution After Weight Loss Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790309
First Posted: November 13, 2008
Last Update Posted: April 21, 2017
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 Medical Center
  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 Naji Abumrad, Vanderbilt University Medical Center:

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 ]

Secondary Outcome Measures:
  • Determine changes in inflammatory markers after weight loss surgery [ Time Frame: 10 days post-op ]

Biospecimen Retention:   Samples With DNA
plasma and serum

Enrollment: 75
Study Start Date: December 2008
Study Completion Date: February 2017
Primary Completion Date: February 2017 (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
Lean
This group will be comprised of normal weight healthy volunteers.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 for surgery groups:

  • BMI of 30 kg/m2 or higher
  • Ages 18-65
  • History of impaired glucose tolerance or T2DM

Inclusion Criteria for normal weight group:

  • BMI of 30 kg/m2 or lower
  • Ages 18-65

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
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): NCT00790309


Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Naji Abumrad, MD 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 Medical Center
ClinicalTrials.gov Identifier: NCT00790309     History of Changes
Other Study ID Numbers: NNA-Early DM Resolution
First Submitted: November 11, 2008
First Posted: November 13, 2008
Last Update Posted: April 21, 2017
Last Verified: April 2017

Keywords provided by Naji Abumrad, Vanderbilt University Medical Center:
Obesity
Diabetes
Bariatric surgery

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