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Mechanisms of Diabetes Relapse After Bariatric Surgery (LAF26)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Blandine Laferrere, Columbia University
ClinicalTrials.gov Identifier:
NCT01516320
First received: January 19, 2012
Last updated: January 30, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Type 2 Diabetes
Procedure: Roux-en-Y Gastric Bypass
Procedure: Laparoscopic adjustable gastric banding
Procedure: Vertical Sleeve Gastrectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Mechanisms of Diabetes Relapse After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Difference in insulin secretion between groups. [ Time Frame: 0 - 48 months after surgery ]
    The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.


Secondary Outcome Measures:
  • 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.

  • Difference in Body composition between groups [ Time Frame: 0 - 48 months after surgery ]
    The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.


Enrollment: 56
Actual Study Start Date: May 13, 2009
Study Completion Date: September 1, 2014
Primary Completion Date: September 1, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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.
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.
Procedure: 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.
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.
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  1. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516320

Locations
United States, New York
New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
Blandine Laferrere
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Blandine Laferrere, MD New York Obesity Nutrition Research Center
  More Information

Additional Information:
Responsible Party: Blandine Laferrere, Professor of Medicine, Columbia University, Columbia University
ClinicalTrials.gov Identifier: NCT01516320     History of Changes
Other Study ID Numbers: AAAO1101  R01DK067561 
Study First Received: January 19, 2012
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Columbia University:
Type 2 Diabetes
Gastric Bypass
Laparoscopic Banding
Vertical Sleeve Gastrectomy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 24, 2017