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

September 12, 2005
February 3, 2009
June 2005
February 2007   (final data collection date for primary outcome measure)
Mean excess weight loss and percent excess weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percent Excess Weight Loss
Complete list of historical versions of study NCT00200018 on ClinicalTrials.gov Archive Site
Diabetes status and use of diabetes medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Diabetes status
Not Provided
Not Provided
 
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
ASSIST: Appetite Suppression Induced by Stimulation Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Severe to Morbid Obesity and Type 2 Diabetes
Device: Enterra Therapy System (H9900014)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
December 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200018
1163-85585
Yes
Kristin Schwartz, Medtronic Neuromodulation
MedtronicNeuro
Not Provided
Study Chair: ASSIST Team Medtronic
MedtronicNeuro
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP