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

This study has been completed.
Information provided by:
MedtronicNeuro Identifier:
First received: September 12, 2005
Last updated: February 3, 2009
Last verified: February 2009

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: ASSIST: Appetite Suppression Induced by Stimulation Trial

Resource links provided by NLM:

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Mean excess weight loss and percent excess weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes status and use of diabetes medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: June 2005
Study Completion Date: December 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00200018

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

No publications provided

Responsible Party: Kristin Schwartz, Medtronic Neuromodulation Identifier: NCT00200018     History of Changes
Other Study ID Numbers: 1163-85585
Study First Received: September 12, 2005
Last Updated: February 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
Morbid obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 22, 2014