Severe to Morbid Obesity and Type 2 Diabetes Clinical Trial
— ASSISTOfficial title:
ASSIST: Appetite Suppression Induced by Stimulation Trial
Verified date | February 2009 |
Source | MedtronicNeuro |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
MedtronicNeuro |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean excess weight loss and percent excess weight loss | 12 months | No | |
Secondary | Diabetes status and use of diabetes medication | 12 months | No |