Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-01-31

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).

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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).

Conditions

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Obesity Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Best Medical Management

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

Group Type ACTIVE_COMPARATOR

Laboratory evaluations, sleep study

Intervention Type OTHER

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

Best Medical Management

Intervention Type OTHER

Standard of care.

Surgical Treatment

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

Group Type ACTIVE_COMPARATOR

Laboratory evaluations, sleep study

Intervention Type OTHER

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

Roux-en-Y gastric bypass surgery

Intervention Type PROCEDURE

Surgical treatment.

Interventions

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Laboratory evaluations, sleep study

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

Intervention Type OTHER

Best Medical Management

Standard of care.

Intervention Type OTHER

Roux-en-Y gastric bypass surgery

Surgical treatment.

Intervention Type PROCEDURE

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No