Mechanisms of Diabetes Relapse After Bariatric Surgery
LAF26
2 other identifiers
interventional
56
1 country
1
Brief Summary
The objective of this study is to investigate the different mechanisms by which Gastric Bypass (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 obese patients with Type 2 Diabetes Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent weight loss and at after surgery in terms of gut hormones levels, insulin secretion and glucose control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started May 2009
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2009
CompletedFirst Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 1, 2017
January 1, 2017
5.3 years
January 19, 2012
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in insulin secretion between groups.
The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.
0 - 48 months after surgery
Secondary Outcomes (2)
Difference in Incretin hormone response between groups.
0 - 48 months after surgery
Difference in Body composition between groups
0 - 48 months after surgery
Study Arms (3)
Gastric Bypass (GBP) Subjects
EXPERIMENTALSubjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.
Laparoscopic adjustable gastric banding (LAGB) Subjects
ACTIVE COMPARATORSubjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity.
Vertical Sleeve Gastrectomy (VSG) Subjects
ACTIVE COMPARATORSubjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.
Interventions
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.
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.
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
You may qualify if:
- 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
- \< BMI \< 50
- Non-Smoker
- Total Body Weight \< 300 LBS
- \<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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
New York, New York, 10025, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Blandine Laferrere, MD
New York Obesity Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine, Columbia University
Study Record Dates
First Submitted
January 19, 2012
First Posted
January 24, 2012
Study Start
May 13, 2009
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share