The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
NCT ID: NCT00547482
Last Updated: 2010-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
300 participants
INTERVENTIONAL
2007-09-30
2009-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
TANTALUS(TM) System
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).
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.
TANTALUS(TM) System
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).
Interventions
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TANTALUS(TM) System
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).
Eligibility Criteria
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Inclusion Criteria
2. Type 2 diabetes \>6 months
3. Type 2 diabetic subjects treated with oral anti-diabetic
4. Stable anti-diabetic medications ≥3 months prior to enrollment, six months for TZD
5. HbA1c ≥7.5% and ≤ 9.5 % at Visit 1, subjects with T2DM duration \> 10 yrs should have HbA1c ≥7.5% and ≤ 9.0
6. Stable HbA1c, Stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications
7. Fasting blood glucose \>120 and \< 240 mg/dl at Visit 1, subjects with T2DM duration \> 10 yrs should be \>120 and ≤180.
8. Women with childbearing potential must agree to use adequate birth control methods
9. Stable weight - no significant change (variation \< 5%) in the last 6 months
10. Willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study
11. Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
12. Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System
13. Alert, mentally competent,
14. Able to provide voluntary informed consent and HIPAA Authorization
Exclusion Criteria
2. Taking GLP-1, Amylin treatment (Byetta, Symlin)
3. Blood pressure levels of \>180/100
4. 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
5. Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
6. Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
7. Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
8. Prior wound healing problems due to Staphylococcus and Candida
9. Prior bariatric surgery
10. History of pancreatitis
11. History of peptic ulcer disease within 5 years of enrollment
12. Diagnosed with gastroparesis
13. 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.
14. Cardiac history that physician feels should exclude the patient
15. Use of another investigational device or agent in the 30 days prior to enrollment
16. A history of life-threatening disease within 5 years of enrollment
17. Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
18 Years
70 Years
ALL
No
Sponsors
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MetaCure (USA), Inc.
INDUSTRY
Responsible Party
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MetaCure (USA), Iinc.
Principal Investigators
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Harold Lebowitz, MD
Role: STUDY_CHAIR
Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science
Locations
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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
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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MC CR TAN2006-067
Identifier Type: -
Identifier Source: org_study_id