A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients

NCT00779363 | Completed DMC

• 1 other identifier: MC CR TAN2007-012
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The objectives of this feasibility study are to evaluate the safety and functionality of the TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on trends of HbA1c, blood glucose and body weight changes.

Conditions

Type 2 Diabetes; Obesity

Keywords

obese,; Diabetes

Outcome Measures

Primary Outcomes (2)

• Safety Evaluation

  June 2004-September2009

• Device Functionality Evaluation

  June 2004-September2009

Secondary Outcomes (2)

• Change in HbA1c

  June 2004-September2009

• Percentage of body weight loss

  June 2004-September2009

Study Arms (1)

Implanted Device

EXPERIMENTAL

Device: rechargeable TANTALUS II

Interventions

rechargeable TANTALUS II DEVICE

Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.

Implanted Device

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-70 years
• Diabetic subjects having HbA1c greater than or equal to 7.5% and less than or equal to 9.5 % at Visit 1
• Sex: male or female. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• Type 2 diabetes duration less than 10 years but at least 6 months
• Type 2 diabetic Subjects taking no more than two (2) oral anti-diabetic agents \[Sulfonylurea, Metformin or thiazolinedione (TZD)\].
• Stable anti-diabetic drugs for at least three (3) months prior to enrollment and six (6) months for thiazolinedione (TZD).
• Fasting blood glucose values \> 120 and \< 240 mg/dl at baseline
• Stable HbA1c, described as no significant change (≤ 0.5% variation) between a historical value in the subjects' medical record within 3 months prior to enrollment and the A1c value gathered at baseline.
• If subject is under anti-depressant medication, the treatment needs to be stable for at least six (6) months prior to enrollment.
• BMI between 28 and 45 (kg/m2)
• Stable weight, defined as no significant weight change over the three months prior to enrollment as reported by the subject (±5 kg).
• Stable medications (including anti-hypertensive and lipid-lowering) for at least one month prior to enrollment.
• Compliant, willing and able to participate in the follow-up visits for the study duration.
• Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial.
• Able to provide voluntary informed consent.

You may not qualify if:

• Gastroparesis or intestinal pseudo-obstruction.
• Receiving medications known to affect gastric motility.
• Taking appetite suppressant or weight loss medications within 1 month of enrollment.
• Diabetic subjects on insulin.
• Past or current psychiatric condition that may impair his or her ability to comply with the study procedures.
• Severe eating disorders such as bulimia or binge eating.
• Obese due to a clinically diagnosed endocrine problem.
• Pregnant (proven by positive βhCG), or lactating.
• History of anemia (\<10 g/dl) over past 3-months.
• Prior bariatric surgery.
• History of peptic ulcer disease.
• Use of another investigational device or agent in the 30 days prior to enrollment.
• Participation in another clinical study.
• Life threatening co-morbidity or life expectancy of less than one year.
• Myocardial Infarction or one or more episodes of unstable angina within six months prior to enrollment.

Sponsors & Collaborators

• MetaCure (USA), Inc.: lead

Study Sites (2)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Diabetes and Glandular Disease Clinic (DGD)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Harold Lebowitz, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: June 1, 2004
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 22, 2016

Record last verified: 2013-04

Locations

US (2)