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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200018
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 5, 2009
Information provided by:

September 12, 2005
September 20, 2005
February 5, 2009
June 2005
February 2007   (Final data collection date for primary outcome measure)
Mean excess weight loss and percent excess weight loss [ Time Frame: 12 months ]
Percent Excess Weight Loss
Complete list of historical versions of study NCT00200018 on Archive Site
Diabetes status and use of diabetes medication [ Time Frame: 12 months ]
Diabetes status
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Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Severe to Morbid Obesity and Type 2 Diabetes
Device: Enterra Therapy System (H9900014)
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Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2007
February 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Kristin Schwartz, Medtronic Neuromodulation
Not Provided
Study Chair: ASSIST Team Medtronic
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP