Early Diabetes Resolution After Weight Loss Surgery
April 20, 2017 updated by: Naji Abumrad, Vanderbilt University Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
75
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects scheduled for weight loss surgery or other abdominal surgeries will be considered for the study.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
Weight loss surgery
|
|
Abdominal surgery
This group will be comprised of people having abdominal surgeries such as nissen fundoplication or cholecystectomy.
|
laparoscopic abdominal surgeries
|
|
Lean
This group will be comprised of normal weight healthy volunteers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery
Time Frame: 10 days post-op
|
10 days post-op
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine changes in inflammatory markers after weight loss surgery
Time Frame: 10 days post-op
|
10 days post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Naji Abumrad, MD, Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
November 11, 2008
First Submitted That Met QC Criteria
November 11, 2008
First Posted (Estimate)
November 13, 2008
Study Record Updates
Last Update Posted (Actual)
April 21, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNA-Early DM Resolution
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.