An observational study in Diabetes, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-01.
Sponsored by NYU Langone Health · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 55 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Bariatric Clinic at Bellevue Hospital
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.
Insulin Resistance
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.
Time frame: 6 months
Vitals status
changes in HBA1c, weight, blood pressure, waist circumference, and levels of fasting lipids
Time frame: 6 Months
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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