Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

David Bradley MD

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Procedure: Roux-en-Y gastric bypass surgery; Other: Best Medical Management; Other: Laboratory evaluations, sleep study

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01044602

2009H0282

MS vs. MM for DM2 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 120 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Best Medical Management

Active Comparator group

Description:

Patients elect to treat obesity and type 2 diabetes mellitus through best medical management.

Treatment:

Other: Best Medical Management

Other: Laboratory evaluations, sleep study

Surgical Treatment

Active Comparator group

Description:

Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.

Treatment:

Other: Laboratory evaluations, sleep study

Procedure: Roux-en-Y gastric bypass surgery