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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014