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

This study has been completed.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200018
First received: September 12, 2005
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200018

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

No publications provided

Responsible Party: Kristin Schwartz, Medtronic Neuromodulation
ClinicalTrials.gov 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:
Obesity
Morbid obesity
Diabetes

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

ClinicalTrials.gov processed this record on May 23, 2013