Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044602

Enrollment

120

Registered

2010-01-08

Start date

2010-01-31

Completion date

2014-01-31

Last updated

2015-04-21

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

Conditions

Obesity, Type 2 Diabetes Mellitus

Keywords

Obesity, Type 2 Diabetes Mellitus, Roux-en-Y Gastric Bypass Surgery

Brief summary

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

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).

Interventions

OTHERLaboratory evaluations, sleep study

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

OTHERBest Medical Management

Standard of care.

PROCEDURERoux-en-Y gastric bypass surgery

Surgical treatment.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026