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NCT01423877 · ClinicalTrials.gov registry record
Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 55
- Enrollment target
NCT01423877: Completed study, sponsored by NYU Langone Health.
NCT01423877 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01423877 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 55 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-09 |
What the finished NCT01423877 record still lists
NCT01423877 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01423877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01423877 about?
NCT01423877 is a clinical study titled "Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35". 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 di...
What is the current status of trial NCT01423877?
This trial is currently completed. The enrollment target is 55 participants. The study started on 2011-08. Estimated completion is 2013-09.
Who is sponsoring clinical trial NCT01423877?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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