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

The Chinese University of Hong Kong

Status and phase: Unknown; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: Tantalus; Drug: Insulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00975533

CRE-2008.335

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Tantalus

Experimental group

Description:

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.

Treatment:

Device: Tantalus

Control

Active Comparator group

Description:

Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.

Treatment:

Drug: Insulin