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

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.

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Key information

Conditions

Severe to Morbid Obesity and Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enterra Therapy System (H9900014)

Device

Primary outcomes

Mean excess weight loss and percent excess weight loss

Time frame: 12 months

Secondary outcomes

Diabetes status and use of diabetes medication

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

ASSIST: Appetite Suppression Induced by Stimulation Trial

Acronym: ASSIST

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Sep 20, 2005
Registry last updated: Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed