NCT00276471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Dec 2005

Typical duration for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1.1 years

First QC Date

January 12, 2006

Last Update Submit

January 31, 2012

Conditions

Type 2 DiabetesObesity

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

Interventions

Implantable pulse generator and electrodesDEVICE

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allgemeinen Krankenhauses der Stadt Wein AkH

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Electrodes

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Bernhard Ludvik, Prof.

    Allgemeinen Krankenhauses der Stadt Wein AkH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

December 1, 2005

Primary Completion

January 1, 2007

Study Completion

June 1, 2007

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

AU(1)