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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: January 19, 2016
Last verified: January 2016

November 11, 2008
January 19, 2016
December 2008
December 2016   (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 ]
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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 ]
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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.
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Observational Model: Case Control
Time Perspective: Prospective
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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
Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
December 2016
December 2016   (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   (Adult)
Contact information is only displayed when the study is recruiting subjects
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NNA-Early DM Resolution
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Naji Abumrad, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Naji Abumrad, MD Vanderbilt University
Vanderbilt University
January 2016

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