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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.
ClinicalTrials.gov Identifier: NCT00200018
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 5, 2009
Information provided by:

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
Severe to Morbid Obesity and Type 2 Diabetes Device: Enterra Therapy System (H9900014)

Study Type : Interventional  (Clinical Trial)
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 : June 2005
Primary Completion Date : February 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Primary Outcome Measures :
  1. Mean excess weight loss and percent excess weight loss [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Diabetes status and use of diabetes medication [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200018

United States, California
La Jolla, California, United States
United States, Minnesota
Eagan, Minnesota, United States
Sponsors and Collaborators
Study Chair: ASSIST Team Medtronic

Responsible Party: Kristin Schwartz, Medtronic Neuromodulation
ClinicalTrials.gov Identifier: NCT00200018     History of Changes
Other Study ID Numbers: 1163-85585
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by MedtronicNeuro:
Morbid obesity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases