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

NCT00547482 | Terminated DMC

• 1 other identifier: MC CR TAN2006-067
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Overweight

Keywords

Type 2 Diabetes; Overweight; Obese

Outcome Measures

Primary Outcomes (1)

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

  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

  The end of the Initial Study Period

Study Arms (2)

Control

SHAM COMPARATOR

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

Treatment

ACTIVE COMPARATOR

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

TANTALUS(TM) System DEVICE

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).

Control; Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• MetaCure (USA), Inc.: lead

Study Sites (10)

Scripps Clinic Del Mar

La Jolla / San Diego, California, 92130, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

University of Colorado at Denver Health Sciences Center

Denver, Colorado, 80262, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Kaleida Health, Diabetes-Endocrinology Center of Western New York

Buffalo, New York, 14209, United States

Location

Comprehensive Weight Control Program Cornell Medical Center

New York, New York, 10021, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

University of Pennsylvania

Pennsylvania, Pennsylvania, 19104-3309, United States

Location

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232, United States

Location

Diabetes and Glandular Disease Clinic (DGD)

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• 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.

  PMID: 12801883 BACKGROUND

• 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.

  PMID: 16687033 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Harold Lebowitz, MD

  Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 22, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 16, 2010

Record last verified: 2008-04

Locations

US (10)