Evaluation of the Tantalus System in Type 2 Diabetic Subjects

MetaCure

Status and phase

Completed

Phase 1

Conditions

Obesity

Type 2 Diabetes

Treatments

Device: Implantable pulse generator and electrodes

Study type

Interventional

Funder types

Industry

Identifiers

NCT00276471

MC PT TAN2005-013

Details and patient eligibility

About

Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.

Enrollment

18 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

T2DM subjects inadequately controlled on a maximum of three oral agents
Subjects with HbA1c between 7 and 9%
Subjects with FBG between 120 and 200 mg/dL
Subjects who are 21-60 years old
Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks
Subjects with Body Mass Index (BMI) between 30-38 (inclusive)
Subjects with waist circumference >94 cm (males) and >80 cm (females)
Subjects on stable medication program for at least three months with any oral medication program
Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks
Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
Able to provide voluntary informed consent.

Exclusion criteria

Subjects at high risk of general anesthesia or surgery
Subjects with prior pancreatitis
Subjects with chronic hepatitis
Subjects with elevated serum creatinine
Subjects with proliferative diabetic retinopathy
Subjects with gastroparesis or intestinal pseudo-obstruction
Subjects with motility disorders of the GI tract
Subjects who are receiving medications known to affect gastric motility
Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
Subjects who are pregnant (proven by positive hCG), or lactating
Subjects who have had prior bariatric surgery
Subjects with a history of peptic ulcer disease
Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study
Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period
Subjects with a life-threatening co-morbidity or life expectancy of less than one year
Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment
Subjects with a history of malignant disease
Subjects who are currently on chemotherapy treatment