Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Diabetes Resolution After Weight Loss Surgery

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.
 
ClinicalTrials.gov Identifier: NCT00790309
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Obesity Diabetes Procedure: Weight loss surgery Procedure: Laparoscopic abdominal surgeries

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery
Study Start Date : December 2008
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Determine changes in inflammatory markers after weight loss surgery [ Time Frame: 10 days post-op ]

Biospecimen Retention:   Samples With DNA
plasma and serum

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for investigator information
Principal Investigator: Naji Abumrad, MD Vanderbilt University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00790309    
Other Study ID Numbers: NNA-Early DM Resolution
First Posted: November 13, 2008    Key Record Dates
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:
Layout table for MeSH terms
Diabetes Mellitus
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Body Weight
Body Weight Changes