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

Medtronic

Status

Completed

Conditions

Severe to Morbid Obesity and Type 2 Diabetes

Treatments

Device: Enterra Therapy System (H9900014)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00200018

1163-85585

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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