Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2009-05-13
2014-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Gastric Bypass (GBP) Subjects
Subjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.
Roux-en-Y Gastric Bypass
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.
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.
Laparoscopic adjustable gastric banding
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.
Vertical Sleeve Gastrectomy (VSG) Subjects
Subjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.
Vertical Sleeve Gastrectomy
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.
Interventions
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Roux-en-Y Gastric Bypass
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.
Laparoscopic adjustable gastric banding
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.
Vertical Sleeve Gastrectomy
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.
Eligibility Criteria
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Inclusion Criteria
* History of Type 2 Diabetes before surgery
* 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
2. 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.
3. Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
4. Currently pregnant or nursing.
5. Known cardiovascular disease
6. Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
7. 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.
8. 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.
9. Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Blandine Laferrere
OTHER
Responsible Party
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Blandine Laferrere
Professor of Medicine, Columbia University
Principal Investigators
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Blandine Laferrere, MD
Role: PRINCIPAL_INVESTIGATOR
New York Obesity Nutrition Research Center
Locations
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New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
New York, New York, United States
Countries
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Related Links
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New York Obesity Nutrition Research Center
Other Identifiers
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AAAO1101
Identifier Type: -
Identifier Source: org_study_id
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