Clinical trial NCT00276471: Evaluation of the Tantalus System in Type 2 Diabetic Subjects
Official title: Evaluation of the Tantalus System in Type 2 Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: MetaCure Limited
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the of device and/or procedure related adverse events
measure: Evaluation of blood chemistry, hematology and urinalysis
measure: Ability to record electrical activity from the stomach
measure: Ability to communicate between patient wand and the device.
Secondary outcomes:
measure: Significant decrease in the HbA1c values between baseline and end-of-treatment
measure: Reduction in the required medications due to improved glycemia.
measure: Significant reduction in weight loss between baseline and end-of-treatment
measure: Improvement in co-morbid parameters
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allgemeinen Krankenhauses der Stadt Wein AkH
Study officials:
affiliation: Allgemeinen Krankenhauses der Stadt Wein AkH
name: Bernhard Ludvik, Prof.
role: PRINCIPAL_INVESTIGATOR
References: