Type 2 Diabetes Mellitus
Conditions
Keywords
type 2 diabetes mellitus, obesity
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-diabetic agents. Study participants will either receive implantation of the gastric contraction modulator or conventional treatment with insulin therapy.
Interventions
DEVICETantalus
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.
DRUGInsulin
Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.
Sponsors
MetaCure Limited
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively) | 6 months and 1 year |
| waist circumferences | 6 month and 1 year |
| differences in insulin requirement | 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 |
Countries
China
Contacts
Primary ContactSimon KH Wong, MBChB
Outcome results
None listed