Early Diabetes Resolution After Weight Loss Surgery
This study is enrolling participants by invitation only.
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00790309
First received: November 11, 2008
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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 | Intervention |
|---|---|
|
Obesity Diabetes |
Procedure: Weight loss surgery Procedure: Laparoscopic abdominal surgeries |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Determine changes in inflammatory markers after weight loss surgery [ Time Frame: 10 days post-op ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
plasma and serum
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00790309 History of Changes |
| Other Study ID Numbers: | NNA-Early DM Resolution |
| Study First Received: | November 11, 2008 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Obesity Diabetes Bariatric surgery |
Additional relevant MeSH terms:
|
Diabetes Mellitus Obesity Weight Loss Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on June 18, 2013