The study is part of a national clinical trial to determine the safety and efficacy of the device for possible treatment for overweight patients with type 2 diabetes.
Participants must be 18 to 70 years of age with type 2 diabetes and have a body mass index (BMI) between 28 and 45*. Those enrolled will undergo a laparoscopic procedure for implantation of the device, which requires an overnight stay at the hospital.
The device consists of a pulse generator that is implanted under the skin near the stomach and leads that are implanted in the gastric muscle. The treatment is based on a new technology called Gastric Contractility Modulation (GCM) that is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation treatment during meal times.
The primary objective of the study is to evaluate the safety and efficacy of the device based on improvement in blood sugar levels (HbA1c), but impact on weight loss, blood pressure and other clinical and metabolic benchmarks will also be studied. The device will be implanted for at least 12 months and up to three years. Study subjects will be randomized into control or treatment groups, evaluated weekly and monthly at the beginning of the study, and then periodically for the remainder of the study.
The national epidemic of type 2 diabetes, most often associated with being overweight, continues to accelerate and affects more than 20 million Americans. About one million people are diagnosed with the metabolic disease annually.
Participants will receive all testing and study-related medical care at no cost and will be compensated for study-related expenses. After the first 12 months, participants will receive semi-annual evaluations for the remaining 2 years until a determination of safety and efficacy is made by the FDA. All information gathered during the study will be kept confidential.
The study is sponsored by MetaCure (USA), Inc., the company that developed the device, which is called the TANTALUS® system.
For more information, please call Colleen Sam at (310) 423-3779 or visit www.cedars-sinai.edu
*Body Mass Index (BMI) is a measure of body fat based on height and weight. Tables and calculation tools can be found at the National Heart Lung and Blood Institute website, which is www.nhlbisupport.com/bmi/
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