Evaluation of the Tantalus System in Type 2 Diabetic Subjects
This study has been completed.
Sponsor:
Metacure
Information provided by:
Metacure
ClinicalTrials.gov Identifier:
NCT00276471
First received: January 12, 2006
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Obesity |
Device: Implantable pulse generator and electrodes |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Tantalus System in Type 2 Diabetic Subjects |
Resource links provided by NLM:
Further study details as provided by Metacure:
Primary Outcome Measures:
- 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
- Ability to communicate between patient wand and the device.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276471
Locations
| Austria | |
| Allgemeinen Krankenhauses der Stadt Wein AkH | |
| Vienna, Austria, 1090 | |
Sponsors and Collaborators
Metacure
Investigators
| Principal Investigator: | Bernhard Ludvik, Prof. | Allgemeinen Krankenhauses der Stadt Wein AkH |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00276471 History of Changes |
| Other Study ID Numbers: | MC PT TAN2005-013 |
| Study First Received: | January 12, 2006 |
| Last Updated: | January 31, 2012 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Obesity Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013