- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516320
Mechanisms of Diabetes Relapse After Bariatric Surgery (LAF26)
Study Overview
Status
Conditions
Detailed Description
The mechanisms of type 2 diabetes (T2DM) remission after gastric bypass surgery (GBP) are unclear. The levels of the gut hormones incretins and their effect on insulin secretion, which is impaired in T2DM, markedly increase after GBP. The anatomical changes of GBP, rather than weight loss, seem to be responsible for the changes of incretins. The objective of this proposal is to investigate the different mechanisms by which GBP, laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly patients with T2DM after GBP, LAGB or VSG.
AIM 1: Will study the short term changes of incretins levels and effect in obese individuals with T2DM after GBP, LAGB or VSG, before and 1 month after GBP or before and after equivalent weight loss after LAGB or VSG.
AIM 2: Will study the long-term (12 and 24 months after surgery) changes in the incretin effect on insulin secretion, in patients with T2DM after GBP, LAGB or VSG.
AIM 3: Will study the changes of insulin secretion to IV glucose (AIRg) and insulin sensitivity (Si), measured by the minimal model, in patients with T2DM after GBP, VSG or LAGB, before and at 24 months after the surgery, at weight stability under condition of controlled diet.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New York
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New York, New York, United States, 10025
- New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Post GBP, LAGB or VSG Subjects
- Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
- History of Type 2 Diabetes before surgery
Inclusion Criteria:
- 35 < BMI < 50
- Non-Smoker
- Total Body Weight < 300 LBS
- 30<Age<60
- HbA1c < 9%
- Resting Blood Pressure < 160/100 mmHg
- Beta Blockers discontinued 2 weeks prior
- Fasting Triglyceride Concentration < 600 mg/dl (patient can be on dyslipidemia medications)
- Without recent (within last 6 months) CHD history (prior history of angioplasty or coronary artery bypass surgery with normal stress test ok)
Exclusion Criteria:
- Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
- Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease.
- Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
- Currently pregnant or nursing.
- Known cardiovascular disease
- Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
- HbA1c >9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment.
- Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test.
- Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gastric Bypass (GBP) Subjects
Subjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.
|
A surgical technique in which the stomach is stapled into a smaller pouch and then attached directly to the small intestine, bypassing the rest of the original stomach.
The goal of the surgery is weight loss.
|
Active Comparator: Laparoscopic adjustable gastric banding (LAGB) Subjects
Subjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity.
|
A surgical technique in which an inflatable silicone device placed around the top portion of the stomach, creating a smaller gastric pouch.
The goal of the surgery is weight loss.
|
Active Comparator: Vertical Sleeve Gastrectomy (VSG) Subjects
Subjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.
|
A surgical technique in which a large portion of the stomach is removed, leaving only a smaller gastric pouch.
The goal of the surgery is weight loss.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in insulin secretion between groups.
Time Frame: 0 - 48 months after surgery
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The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.
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0 - 48 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Incretin hormone response between groups.
Time Frame: 0 - 48 months after surgery
|
The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.
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0 - 48 months after surgery
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Difference in Body composition between groups
Time Frame: 0 - 48 months after surgery
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The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.
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0 - 48 months after surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAO1101
- R01DK067561 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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