A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients

Completed · Not applicable

Conditions studied: Type 2 Diabetes, Obesity

In brief

The objectives of this feasibility study are to evaluate the safety and functionality of the TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on trends of HbA1c, blood glucose and body weight changes.

Key facts

Study ID

NCT00779363

Run by

MetaCure (USA), Inc.

People needed

14

Starts

2004-06-01

Expected to finish

2009-11-01

Last updated by the study team

2016-09-22

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21-70 years
• Diabetic subjects having HbA1c greater than or equal to 7.5% and less than or equal to 9.5 % at Visit 1
• Sex: male or female. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• Type 2 diabetes duration less than 10 years but at least 6 months
• Type 2 diabetic Subjects taking no more than two (2) oral anti-diabetic agents [Sulfonylurea, Metformin or thiazolinedione (TZD)].
• Stable anti-diabetic drugs for at least three (3) months prior to enrollment and six (6) months for thiazolinedione (TZD).
• Fasting blood glucose values > 120 and < 240 mg/dl at baseline
• Stable HbA1c, described as no significant change (≤ 0.5% variation) between a historical value in the subjects' medical record within 3 months prior to enrollment and the A1c value gathered at baseline.
• If subject is under anti-depressant medication, the treatment needs to be stable for at least six (6) months prior to enrollment.
• BMI between 28 and 45 (kg/m2)
• Stable weight, defined as no significant weight change over the three months prior to enrollment as reported by the subject (±5 kg).
• Stable medications (including anti-hypertensive and lipid-lowering) for at least one month prior to enrollment.
• Compliant, willing and able to participate in the follow-up visits for the study duration.
• Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial.
• Able to provide voluntary informed consent.

You may not qualify if…

• Gastroparesis or intestinal pseudo-obstruction.
• Receiving medications known to affect gastric motility.
• Taking appetite suppressant or weight loss medications within 1 month of enrollment.
• Diabetic subjects on insulin.
• Past or current psychiatric condition that may impair his or her ability to comply with the study procedures.
• Severe eating disorders such as bulimia or binge eating.
• Obese due to a clinically diagnosed endocrine problem.
• Pregnant (proven by positive βhCG), or lactating.
• History of anemia (<10 g/dl) over past 3-months.
• Prior bariatric surgery.
• History of peptic ulcer disease.
• Use of another investigational device or agent in the 30 days prior to enrollment.
• Participation in another clinical study.
• Life threatening co-morbidity or life expectancy of less than one year.
• Myocardial Infarction or one or more episodes of unstable angina within six months prior to enrollment.
• Implanted with a permanent pacemaker, an automatic implantable defibrillator, or other electro-stimulation device.
• History of life threatening disease within 5 years of enrollment.
• Use of routine ulcerogenic drugs.
• Use of prescription, over the counter or herbal weight loss products.

Where it is running

• Cedars Sinai — Los Angeles, California, United States
• Diabetes and Glandular Disease Clinic (DGD) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.