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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by MedtronicNeuro:
Morbid obesity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity, Morbid
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on June 23, 2017