Back to resultsStudy of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes (ASSIST)
Primary Purpose
Severe to Morbid Obesity and Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enterra Therapy System (H9900014)
Sponsored by
About this trial
This is an interventional treatment trial for Severe to Morbid Obesity and Type 2 Diabetes focused on measuring Obesity, Morbid obesity, Diabetes
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Mean excess weight loss and percent excess weight loss
Secondary Outcome Measures
Diabetes status and use of diabetes medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00200018
Brief Title
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
Acronym
ASSIST
Official Title
ASSIST: Appetite Suppression Induced by Stimulation Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MedtronicNeuro
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe to Morbid Obesity and Type 2 Diabetes
Keywords
Obesity, Morbid obesity, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Enterra Therapy System (H9900014)
Primary Outcome Measure Information:
Title
Mean excess weight loss and percent excess weight loss
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Diabetes status and use of diabetes medication
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ASSIST Team
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
La Jolla
State/Province
California
Country
United States
City
Eagan
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
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