Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Severe to Morbid Obesity and Type 2 Diabetes

• Registration Number: NCT00200018
• Lead Sponsor: MedtronicNeuro

Brief Summary

The purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-02
• Study Completion: 2007-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Type 2 diabetes with HbA1c of 7.5 - 11%
• Willing to make behavior and lifestyle modifications
• No previous bariatric surgery (gastric bypass, gastric banding)
• Meet additional study criteria

Exclusion Criteria

• History of substance abuse or chemical dependency with in the last 3 years
• Prior GI surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes
• Severe congestive heart failure
• Any underlying illness other than diabetes or obesity that affects gastrointestinal motility
• Currently taking medications for weight loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean excess weight loss and percent excess weight loss	12 months

Secondary Outcome Measures

Name	Time	Method
Diabetes status and use of diabetes medication	12 months