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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:
ClinicalTrials.gov Identifier:
NCT00200018
First Posted: September 20, 2005
Last Update Posted: February 5, 2009
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.
Information provided by:
MedtronicNeuro
  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
Intervention Model: Parallel Assignment
Masking: Double (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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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

Responsible Party: Kristin Schwartz, Medtronic Neuromodulation
ClinicalTrials.gov Identifier: NCT00200018     History of Changes
Other Study ID Numbers: 1163-85585
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by MedtronicNeuro:
Obesity
Morbid obesity
Diabetes

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