Clinical trial NCT00975533: Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
obesity
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: MetaCure Limited
First posted: 2009-09-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: changes in body weight before and after interventions at 6 and 12 months
timeFrame: 6 months and 1 year
measure: changes in HbA1c before and after interventions
timeFrame: 6 and 12 months
measure: frequency of hypoglycaemia
timeFrame: 6 month and 1 year
measure: 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
timeFrame: 6 and 12 months
measure: composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia
timeFrame: 6 month and 1 year
Secondary outcomes:
measure: waist circumferences
timeFrame: 6 month and 1 year
measure: insulin secretory responses (as measured by the standard meal test)
timeFrame: 6 month and 1 year
measure: Hormonal profiles (including gut hormones)
timeFrame: 6 months and 1 year
measure: 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
timeFrame: 6 month and 1 year
measure: resting energy expenditure as monitored by indirect calorimetry (MedGem).
timeFrame: 6 month and 1 year
measure: radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively)
timeFrame: 6 months and 1 year
measure: differences in insulin requirement
timeFrame: 1 year
Other outcomes:
Locations:
city: Shatin
country: China
facility: Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon KH Wong, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong SK, Kong AP, Luk AO, Ozaki R, Ng VW, Lebovitz HE, Ng EK, Chan JC. A pilot study to compare meal-triggered gastric electrical stimulation and insulin treatment in Chinese obese type 2 diabetes. Diabetes Technol Ther. 2015 Apr;17(4):283-90. doi: 10.1089/dia.2014.0234. Epub 2015 Feb 24.