Status:
COMPLETED
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
Lead Sponsor:
MedtronicNeuro
Conditions:
Severe to Morbid Obesity and Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00200018
Start Date
June 1 2005
End Date
December 1 2007
Last Update
February 5 2009
Active Locations (2)
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1
La Jolla, California, United States
2
Eagan, Minnesota, United States