Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Early Diabetes Resolution After Weight Loss Surgery

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University Identifier:
First received: November 11, 2008
Last updated: December 8, 2014
Last verified: December 2014

November 11, 2008
December 8, 2014
December 2008
December 2015   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00790309 on Archive Site
Determine changes in inflammatory markers after weight loss surgery [ Time Frame: 10 days post-op ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Early Diabetes Resolution After Weight Loss Surgery
Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery

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.

Not Provided
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA

plasma and serum

Non-Probability Sample

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

  • Obesity
  • Diabetes
  • Procedure: Weight loss surgery
    Weight loss surgery
  • Procedure: Laparoscopic abdominal surgeries
    laparoscopic abdominal surgeries
  • 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
    Intervention: Procedure: Weight loss surgery
  • Abdominal surgery
    This group will be comprised of people having abdominal surgeries such as nissen fundoplication or cholecystectomy.
    Intervention: Procedure: Laparoscopic abdominal surgeries
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
December 2015
December 2015   (final data collection date for primary outcome measure)

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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
Not Provided
NNA-Early DM Resolution
Naji Abumrad, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Naji Abumrad, MD Vanderbilt University
Vanderbilt University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP