Status:
UNKNOWN
Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
MetaCure Limited
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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-diabe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00975533
Start Date
October 1 2009
End Date
October 1 2011
Last Update
September 11 2009
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, Hong Kong, China