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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Tantalus	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. The device is intended to improve glycemic control and induce weight loss.
Control	Insulin	Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.

Primary Outcome Measures

Name	Time	Method
changes in body weight before and after interventions at 6 and 12 months	6 months and 1 year
changes in HbA1c before and after interventions	6 and 12 months
frequency of hypoglycaemia	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	6 and 12 months
composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia	6 month and 1 year

Secondary Outcome Measures

Name	Time	Method
waist circumferences	6 month and 1 year
insulin secretory responses (as measured by the standard meal test)	6 month and 1 year
Hormonal profiles (including gut hormones)	6 months and 1 year
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	6 month and 1 year
resting energy expenditure as monitored by indirect calorimetry (MedGem).	6 month and 1 year
radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively)	6 months and 1 year
differences in insulin requirement	1 year

Recruitment & Eligibility