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

February 3, 2009 updated by: MedtronicNeuro

ASSIST: Appetite Suppression Induced by Stimulation Trial

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.

Study Overview

Status

Completed

Conditions

Severe to Morbid Obesity and Type 2 Diabetes

Intervention / Treatment

Device: Enterra Therapy System (H9900014)

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - La Jolla, California, United States
- Minnesota
  - Eagan, Minnesota, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean excess weight loss and percent excess weight loss Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diabetes status and use of diabetes medication Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

Study Chair: ASSIST Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria