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TerminatedNCT00547482Updated Dec 16, 2010

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

An interventional study of TANTALUS(TM) System in Type 2 Diabetes Mellitus and Overweight, sponsored by MetaCure (USA), Inc.. Terminated at 10 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-12-16.

Sponsored by MetaCure (USA), Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Protocol design under review.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Overweight

Keywords

  • Type 2 Diabetes
  • Overweight
  • Obese
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 300 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

MetaCure (USA), Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Body mass index (BMI) ≥ 28 and ≤ 45 (kg/m2)
  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

Exclusion Criteria:

  1. Receiving insulin therapy
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • 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.

    Device: TANTALUS(TM) System

  • 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.

    Device: TANTALUS(TM) System

Interventions

  • DeviceTANTALUS(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).

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

10 sites
  • Scripps Clinic Del Mar
    La Jolla / San Diego, California 92130, United States
  • Cedars Sinai
    Los Angeles, California 90048, United States
  • University of Colorado at Denver Health Sciences Center
    Denver, Colorado 80262, United States
  • Washington University School of Medicine in St. Louis
    St. Louis, Missouri 63110, United States
  • Kaleida Health, Diabetes-Endocrinology Center of Western New York
    Buffalo, New York 14209, United States
  • Comprehensive Weight Control Program Cornell Medical Center
    New York, New York 10021, United States
  • Mt. Sinai School of Medicine
    NY, New York 10029-6574, United States
  • University of Pennsylvania
    Pennsylvania, Pennsylvania 19104-3309, United States
  • Vanderbilt University School of Medicine
    Nashville, Tennessee 37232, United States
  • Diabetes and Glandular Disease Clinic (DGD)
    San Antonio, Texas 78229, United States
08

References and documents

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. PubMed 12801883 ↗
  • 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. PubMed 16687033 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00547482
Lead sponsor
MetaCure (USA), Inc.
First posted
Oct 22, 2007
Start date
Sep 2007
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Dec 16, 2010

Study contacts

Harold Lebowitz, MD
study chair · Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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