Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study

Conditions
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Obesity, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Laboratory evaluations, sleep study
* Other: Best Medical Management
* Procedure: Roux-en-Y gastric bypass surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Best Medical Management<br>Patients elect to treat obesity and type 2 diabetes mellitus through best medical management. | Other: Laboratory evaluations, sleep study<br>* Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.<br>Other: Best Medical Management<br>* Standard of care.<br>|
| Active Comparator: Surgical Treatment<br>Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass. | Other: Laboratory evaluations, sleep study<br>* Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.<br>Procedure: Roux-en-Y gastric bypass surgery<br>* Surgical treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test. |  | 2 years | 
| Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in glucose control |  | 2 years | 
| Improvement in control of chronic co-morbidities |  | 2 years | 
| Identify predictors of success with regard to improved co-morbidities and velocity of weight loss |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Type 2 Diabetes Mellitus, Roux-en-Y Gastric Bypass Surgery