- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00547482
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind and controlled, multi-center study. Three hundred (300) subjects with type 2 diabetes ranging from low BMI to BMI 45 (BMI ≥ 28 and ≤ 45) will be enrolled.
The duration of subject participation in the main portion of the study which includes the initial study and study extension periods is expected to be approximately 12 months. Upon completion of this period, subjects with a TANTALUS device shall continue to be followed clinically at six-month intervals (Safety Monitoring Period) until the FDA has made a determination regarding the safety and efficacy of the device.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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La Jolla / San Diego, California, United States, 92130
- Scripps Clinic Del Mar
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Los Angeles, California, United States, 90048
- Cedars Sinai
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado at Denver Health Sciences Center
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine in St. Louis
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New York
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Buffalo, New York, United States, 14209
- Kaleida Health, Diabetes-Endocrinology Center of Western New York
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NY, New York, United States, 10029-6574
- Mt. Sinai School of Medicine
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New York, New York, United States, 10021
- Comprehensive Weight Control Program Cornell Medical Center
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Pennsylvania
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Pennsylvania, Pennsylvania, United States, 19104-3309
- University of Pennsylvania
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University School of Medicine
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Texas
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San Antonio, Texas, United States, 78229
- Diabetes and Glandular Disease Clinic (DGD)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control
They will all be implanted but not activated for the Initial Study Period (24 weeks), followed by all subjects assigned to treatment (Control Group with device activation) in the Study Extension Period (an additional 24 weeks).
Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.
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All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation).
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Active Comparator: Treatment
All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation).
They will be followed for the Initial Study Period (24 weeks), followed by the Study Extension Period (an additional 24 weeks).
Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.
|
All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycemic control as measured by HbA1c: Difference in mean reduction between Control and Treatment Groups will be evaluated.
Time Frame: At the end of the Initial Study Period
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At the end of the Initial Study Period
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Device/procedure-related adverse events;hypoglycemic events; Proportion of subjects with HbA1c less than 7.0;reduction of weight for both groups;improvement of glycemic control as measured by HbA1c
Time Frame: The end of the Initial Study Period
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The end of the Initial Study Period
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Harold Lebowitz, MD, Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science
Publications and helpful links
General Publications
- Peles S, Petersen J, Aviv R, Policker S, Abu-Hatoum O, Ben-Haim SA, Gutterman DD, Sengupta JN. Enhancement of antral contractions and vagal afferent signaling with synchronized electrical stimulation. Am J Physiol Gastrointest Liver Physiol. 2003 Sep;285(3):G577-85. doi: 10.1152/ajpgi.00109.2003. Epub 2003 Jun 11.
- Bohdjalian A, Prager G, Aviv R, Policker S, Schindler K, Kretschmer S, Riener R, Zacherl J, Ludvik B. One-year experience with Tantalus: a new surgical approach to treat morbid obesity. Obes Surg. 2006 May;16(5):627-34. doi: 10.1381/096089206776945101.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC CR TAN2006-067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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