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Early Diabetes Resolution After Weight Loss Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00790309
First received: November 11, 2008
Last updated: April 20, 2017
Last verified: April 2017

November 11, 2008
April 20, 2017
December 2008
February 2017   (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 ]
Not Provided
Complete list of historical versions of study NCT00790309 on ClinicalTrials.gov Archive Site
Determine changes in inflammatory markers after weight loss surgery [ Time Frame: 10 days post-op ]
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
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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
  • Lean
    This group will be comprised of normal weight healthy volunteers.
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
February 2017
February 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00790309
NNA-Early DM Resolution
No
Not Provided
Not Provided
Not Provided
Naji Abumrad, Vanderbilt University Medical Center
Vanderbilt University Medical Center
Not Provided
Principal Investigator: Naji Abumrad, MD Vanderbilt University Medical Center
Vanderbilt University Medical Center
April 2017

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