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

Type 2 Diabetes Mellitus Clinical 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00975533
• Other study ID #: CRE-2008.335
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 10, 2009
• Last updated: September 10, 2009
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2009
• Source: Chinese University of Hong Kong
• Contact: Simon KH Wong, MBChB
• Phone: 852-26322627
• Email: wongkhmo[@]cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health, Hong Kong SAR
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• 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.

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

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Shatin	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Metacure

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in body weight before and after interventions at 6 and 12 months		6 months and 1 year	No
Primary	changes in HbA1c before and after interventions		6 and 12 months	No
Primary	frequency of hypoglycaemia		6 month and 1 year	Yes
Primary	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	Yes
Primary	composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia		6 month and 1 year	No
Secondary	waist circumferences		6 month and 1 year	No
Secondary	insulin secretory responses (as measured by the standard meal test)		6 month and 1 year	No
Secondary	Hormonal profiles (including gut hormones)		6 months and 1 year	No
Secondary	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	No
Secondary	resting energy expenditure as monitored by indirect calorimetry (MedGem).		6 month and 1 year	No
Secondary	radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively)		6 months and 1 year	No
Secondary	differences in insulin requirement		1 year	No