Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01423877
First received: August 24, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

Specific Aims & Hypothesis Primary Aim: To evaluate laparoscopic bariatric surgery versus intensive medical weight management on indices of insulin resistance and resolution of type 2 diabetes among patients with BMI 30-35.

Hypothesis: Bariatric surgery is the most effective treatment to induce diabetes remission in obese diabetic patients BMI 30-35.

The primary outcomes will be assessed at 6 months: (1) within-patient change in insulin resistance after either bariatric surgery or initiation of intensive medical weight management, and (2) remission of diabetes, (i.e., fasting glucose <126mg/dL and glucose <200mg/dL two hours after a standard 75g oral glucose load without the use of anti-hyperglycemic medications). Insulin resistance will be assessed at randomization and at 6 months with the homeostatic model assessment of insulin resistance (HOMA IR) based on insulin and fasting glucose, as well as oral glucose tolerance tests with area-under-the-curve (AUC) measurement for insulin values. Medication discontinuation will be derived from electronic health records and patient self-report at 6 months. Secondary outcomes will include changes in HBA1c, weight, blood pressure, waist circumference, and levels of fasting lipids.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Insulin Resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Within-patient change in insulin resistance after either bariatric surgery or initiation of intensive medical weight management, and remission of diabetes, (i.e., fasting glucose <126mg/dL and glucose <200mg/dL two hours after a standard 75g oral glucose load without the use of anti-hyperglycemic medications). Insulin resistance will be assessed at randomization and at 6 months with the homeostatic model assessment of insulin resistance (HOMA IR) based on insulin and fasting glucose, as well as oral glucose tolerance tests with area-under-the-curve (AUC) measurement for insulin values.


Secondary Outcome Measures:
  • Vitals status [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    changes in HBA1c, weight, blood pressure, waist circumference, and levels of fasting lipids


Estimated Enrollment: 55
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Bariatric Clinic at Bellevue Hospital

Criteria

Inclusion Criteria:

Patients eligible for study are adults (age ≥ 18) with type 2 diabetes who have a BMI 30-35, and are insured by Metroplus insurance, but otherwise meet NIH Consensus Criteria specifically (1) overweight for at least 5 years, (2) failure to lose weight with non-surgical means, (3) absence of medical or psychological contraindications, and (4) patient understanding of the procedure and its risks, and strong motivation to comply with the post-surgical regimen. Patients must have permission from their physician to participate in the study.

Exclusion Criteria:

Exclusions include being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks), participation in other obesity- or diabetes-related clinical trials, or diagnosis of cognitive dysfunction or significant psychiatric comorbidity.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01423877

Locations
United States, New York
Bellevue Hospital Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01423877     History of Changes
Other Study ID Numbers: 11-00808
Study First Received: August 24, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
bariatric surgery
diabetes
sleeve gastrectomy
gastric bypass
gastric banding

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

ClinicalTrials.gov processed this record on July 22, 2014