Evaluation of the Tantalus System in Type 2 Diabetic Subjects

This study has been completed.
Sponsor:
Information provided by:
Metacure
ClinicalTrials.gov Identifier:
NCT00276471
First received: January 12, 2006
Last updated: January 31, 2012
Last verified: January 2012
  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 April 14, 2014