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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.
Prince of Wales Hospital
Shatin, Hong Kong, China
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
frequency of hypoglycaemia
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
composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia
Time frame: 6 month and 1 year
waist circumferences
Time frame: 6 month and 1 year
insulin secretory responses (as measured by the standard meal test)
Time frame: 6 month and 1 year
Hormonal profiles (including gut hormones)
Time frame: 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
Time frame: 6 month and 1 year
resting energy expenditure as monitored by indirect calorimetry (MedGem).
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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
differences in insulin requirement
Time frame: 1 year