The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

Stopped early · Not applicable

Conditions studied: Type 2 Diabetes Mellitus, Overweight

In brief

The main purpose of this research study is to investigate whether the TANTALUS II System is effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes (high blood sugar) and are overweight. The research will also evaluate the impact on weight loss and will study other health conditions related to obesity. This research study involves an experimental system. The experimental system is the TANTALUS System, which consists of the implantable portion that includes the implantable pulse generator (IPG) and three pairs of implantable leads. There are also three external parts (items that are used outside your body): the programmer, the charger, and the Patient Wand.

Key facts

Study ID

NCT00547482

Run by

MetaCure (USA), Inc.

People needed

300

Starts

2007-09-01

Expected to finish

2009-11-01

Last updated by the study team

2010-12-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index (BMI) ≥ 28 and ≤ 45 (kg/m2)
• Type 2 diabetes >6 months
• Type 2 diabetic subjects treated with oral anti-diabetic
• Stable anti-diabetic medications ≥3 months prior to enrollment, six months for TZD
• HbA1c ≥7.5% and ≤ 9.5 % at Visit 1, subjects with T2DM duration > 10 yrs should have HbA1c ≥7.5% and ≤ 9.0
• Stable HbA1c, Stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications
• Fasting blood glucose >120 and < 240 mg/dl at Visit 1, subjects with T2DM duration > 10 yrs should be >120 and ≤180.
• Women with childbearing potential must agree to use adequate birth control methods
• Stable weight - no significant change (variation < 5%) in the last 6 months
• Willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study
• Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
• Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System
• Alert, mentally competent,
• Able to provide voluntary informed consent and HIPAA Authorization

You may not qualify if…

• Receiving insulin therapy
• Taking GLP-1, Amylin treatment (Byetta, Symlin)
• Blood pressure levels of >180/100
• Patients with an EF less than 35% (obtained within last 6 months) or indicated for an ICD; if echocardiogram outdated or unavailable, procedure to be done
• Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
• Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
• Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
• Prior wound healing problems due to Staphylococcus and Candida
• Prior bariatric surgery
• History of pancreatitis
• History of peptic ulcer disease within 5 years of enrollment
• Diagnosed with gastroparesis
• Use of active medical devices (either implantable or external) such as ICD, pacemaker, neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
• Cardiac history that physician feels should exclude the patient
• Use of another investigational device or agent in the 30 days prior to enrollment
• A history of life-threatening disease within 5 years of enrollment
• Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study

Where it is running

• Scripps Clinic Del Mar — La Jolla / San Diego, California, United States
• Cedars Sinai — Los Angeles, California, United States
• University of Colorado at Denver Health Sciences Center — Denver, Colorado, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Kaleida Health, Diabetes-Endocrinology Center of Western New York — Buffalo, New York, United States
• Comprehensive Weight Control Program Cornell Medical Center — New York, New York, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• University of Pennsylvania — Pennsylvania, Pennsylvania, United States
• Vanderbilt University School of Medicine — Nashville, Tennessee, 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.