Obesity, Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DEVICEImplantable pulse generator and electrodes
Sponsors
MetaCure Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to communicate between patient wand and the device. | — |
| Evaluation of the of device and/or procedure related adverse events | — |
| Evaluation of blood chemistry, hematology and urinalysis | — |
| Ability to record electrical activity from the stomach | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant decrease in the HbA1c values between baseline and end-of-treatment | — |
| Reduction in the required medications due to improved glycemia. | — |
| Significant reduction in weight loss between baseline and end-of-treatment | — |
| Improvement in co-morbid parameters | — |
Countries
Austria
Outcome results
None listed