Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00975533
• Date of registration: 10/09/2009
• Primary sponsor: Chinese University of Hong Kong
• Public title: Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial
• Scientific title: 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.
• Date of first enrolment: October 2009
• Target sample size: 24
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00975533
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Simon KH Wong, MBChB

• Name: Simon KH Wong, MBChB
• Affiliation: Chinese University of Hong Kong

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Device: Tantalus

Drug: Insulin

Primary Outcome(s)

changes in body weight before and after interventions at 6 and 12 months [Time Frame: 6 months and 1 year]

changes in HbA1c before and after interventions [Time Frame: 6 and 12 months]

composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia [Time Frame: 6 month and 1 year]

dichotomous composite end point assessing the proportion of patients meeting all of the following prespecified criteria defined as: 1. HbA1c =7.0% or an HbA1c reduction from baseline =0.5% 2. no weight gain 3. no severe hypoglycaemia [Time Frame: 6 and 12 months]

frequency of hypoglycaemia [Time Frame: 6 month and 1 year]

Secondary Outcome(s)

a. eating behavior, satiety and quality of life as measured by the Food Frequency Questionnaire, Visual Analogue Rating Scale To Assess Satiety, EDE, SF-36 and GIQOL questionnaires [Time Frame: 6 month and 1 year]

differences in insulin requirement [Time Frame: 1 year]

Hormonal profiles (including gut hormones) [Time Frame: 6 months and 1 year]

insulin secretory responses (as measured by the standard meal test) [Time Frame: 6 month and 1 year]

radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively) [Time Frame: 6 months and 1 year]

resting energy expenditure as monitored by indirect calorimetry (MedGem). [Time Frame: 6 month and 1 year]

waist circumferences [Time Frame: 6 month and 1 year]

Secondary ID(s)

CRE-2008.335

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Metacure