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Type 2 Diabetes MellitusNCT00547482

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

A study testing TANTALUS(TM) System in people with Type 2 Diabetes Mellitus and Overweight, run by MetaCure (USA), Inc. at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus, Overweight
What is being tested?
TANTALUS(TM) System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
10 sitesUnited States
Study dates
Sep 2007to Nov 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Kaleida Health, Diabetes-Endocrinology Center of Western New York

    Buffalo, New York, 14209

  • University of Colorado at Denver Health Sciences Center

    Denver, Colorado, 80262

  • Scripps Clinic Del Mar

    La Jolla / San Diego, California, 92130

  • Cedars Sinai

    Los Angeles, California, 90048

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232

  • Comprehensive Weight Control Program Cornell Medical Center

    New York, New York, 10021

  • Mt. Sinai School of Medicine

    New York, New York, 10029-6574

  • University of Pennsylvania

    Pennsylvania, Pennsylvania, 19104-3309

  • Diabetes and Glandular Disease Clinic (DGD)

    San Antonio, Texas, 78229

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this 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.

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.

Being tested
TANTALUS(TM) System
Keywords
Type 2 Diabetes, Overweight, Obese
Medical subject headings
Diabetes Mellitus, Type 2, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TANTALUS(TM) SystemDevice

    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).

Study groups in NCT00547482
Study groupRoleWhat they receive
ControlSham comparatorThey 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.
Receives: Device: TANTALUS(TM) System
TreatmentActive comparatorAll 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.
Receives: Device: TANTALUS(TM) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control as measured by HbA1c: Difference in mean reduction between Control and Treatment Groups will be evaluated.

    Measured: At the end of the Initial Study Period

Secondary outcomes (1)

  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

    Measured: The end of the Initial Study Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionNov 2009
  4. Study completionNov 2009

Why it stopped: Protocol design under review.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00547482
Sponsor's protocol ID
MC CR TAN2006-067
Status last verified
Apr 2008
First submitted
4 Oct 2007
Last updated
16 Dec 2010
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing TANTALUS(TM) System in people with Type 2 Diabetes Mellitus and Overweight, run by MetaCure (USA), Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Protocol design under review.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00547482, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2010; AzTrials last refreshed its copy on 7 Nov 2026.

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