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

Severe to Morbid Obesity and Type 2 Diabetes Clinical Trial

— ASSIST  

Official title:

ASSIST: Appetite Suppression Induced by Stimulation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200018
• Other study ID #: 1163-85585
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: February 3, 2009
• Start date: June 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2009
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity, Morbid
• Severe to Morbid Obesity and Type 2 Diabetes

Intervention

Device:
• Enterra Therapy System (H9900014)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean excess weight loss and percent excess weight loss		12 months	No
Secondary	Diabetes status and use of diabetes medication		12 months	No