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

Sponsor

MedtronicNeuro (Industry)

Overall Status

Completed

CT.gov ID

NCT00200018

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe to Morbid Obesity and Type 2 Diabetes	Device: Enterra Therapy System (H9900014)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

ASSIST: Appetite Suppression Induced by Stimulation Trial

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Mean excess weight loss and percent excess weight loss [12 months]

Secondary Outcome Measures

Diabetes status and use of diabetes medication [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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