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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01423877

Enrollment

Registered

2011-08-26

Start date

2011-08-31

Completion date

2013-09-30

Last updated

2014-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

bariatric surgery, diabetes, sleeve gastrectomy, gastric bypass, gastric banding

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Insulin Resistance	6 months	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

Measure	Time frame	Description
Vitals status	6 Months	changes in HBA1c, weight, blood pressure, waist circumference, and levels of fasting lipids

Countries

United States

Outcome results