Trial | NCT00975533  Report issue

Title

Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial
A Randomized Study to Evaluate the Efficacy and Acceptability of Laparoscopic Placement of Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients Sub-optimally Controlled With Oral Anti-diabetic Agents.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    24
This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at least 2 anti-diabetic agents. Study participants will either receive implantation of the gastric contraction modulator or conventional treatment with insulin therapy.
Study Started
Oct 31
2009
Primary Completion
Jul 31
2011
Anticipated
Study Completion
Oct 31
2011
Anticipated
Last Update
Sep 11
2009
Estimate

Device Tantalus

The TANTALUS System is implanted using minimally invasive procedure (laparoscopy). It uses leads with stitch electrodes to deliver electrical signals to the gastric wall for the treatment of obese subjects with T2DM.

Drug Insulin

Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.

Control Active Comparator

Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.

Tantalus Experimental

The TANTALUS System is implanted using minimally invasive procedure (laparoscopy). It uses leads with stitch electrodes to deliver electrical signals to the gastric wall for the treatment of obese subjects with T2DM. The device is intended to improve glycemic control and induce weight loss.

Criteria 

Inclusion Criteria:

Able to provide written informed consent
Adult patients aged between 18 and 60 years (inclusive)
Male or female of Chinese ethnicity
Type 2 diabetes mellitus with disease duration of greater than 2 and less than 10 years
severe obesity, includes BMI 25 to 27.5 kg/m and central obesity defined by waist circumference greater than 90 cm in women and greater than 95 in men, or BMI greater than 27.5 to less than 35 kg/m
HbA1c greater than or equals to 7.5% but less than 10% despite treated with maximum dose or maximally tolerated dose of 2 anti-diabetic drugs (OAD) with good drug compliance

Exclusion Criteria:

On anti-obesity drugs
On insulin treatment at the time of the recruitment
On glitazone or incretins (dipeptidyl peptidase-4 inhibitor or glucagons-like peptide-1) treatment
On any implantable device including cardiac pacing
Anticipated to have MRI examinations
Fasting C-peptide level less than 0.5g/L
Renal impairment (defined as serum creatinine greater than 150mol/L and/or estimated glomerular filtration rate less than 60 mL/min/1.73m)
Significant liver impairment (ALT more than 3 times upper limit of normal range)
Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
Active infection
Active and uncontrolled thyroid diseases
Childbearing age female patients without reliable contraceptive methods
Life expectancy less than 12 months
Administration of another investigational drugs or procedures within 4 weeks before screening
Any medical illness or condition as judged by the investigators as ineligible to participate the study
Special population, e.g. prisoner, mentally disabled, investigators' student or employees
No Results Posted