Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

David Bradley MD120 enrolled

Overview

Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).

Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Obesity Type 2 Diabetes Mellitus

Interventions

Laboratory evaluations, sleep studyOTHER

Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.

Best Medical ManagementOTHER

Standard of care.

Roux-en-Y gastric bypass surgeryPROCEDURE

Surgical treatment.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 25 to 70 * BMI 35 or greater * HbA1c\>6.5% * Stable weight * Stable medications Exclusion Criteria: * Coagulopathy * Liver cirrhosis * C-peptide \<1 ng/ml (off insulin) * Diagnosis of severe eating disorder * Untreated endocrine disorder * Use of medication for weight loss in the past 6 months * Use of medication for weight loss in the last 6 months (with the exception of orlistat) * Pregnancy * Coagulopathy * Liver cirrhosis * Incurable, malignant, or debilitating disease * Severe eating disorder * Use of weight loss medication in the last 6 months, with the exception of orlistat * Untreated endocrine disorder * Pregnant * Inability to provide informed consent

Locations (1)

The Ohio State University Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.

Time frame: 2 years

Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia

Time frame: 2 years

Secondary Outcomes

Improvement in glucose control

Time frame: 2 years

Improvement in control of chronic co-morbidities

Time frame: 2 years

Identify predictors of success with regard to improved co-morbidities and velocity of weight loss

Time frame: 2 years

Data from ClinicalTrials.gov

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