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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tantalus
Insulin
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tantalus

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

changes in body weight before and after interventions at 6 and 12 months
changes in HbA1c before and after interventions
frequency of hypoglycaemia
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
composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia

Secondary Outcome Measures

waist circumferences
insulin secretory responses (as measured by the standard meal test)
Hormonal profiles (including gut hormones)
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
resting energy expenditure as monitored by indirect calorimetry (MedGem).
radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively)
differences in insulin requirement

Full Information

First Posted
September 10, 2009
Last Updated
September 10, 2009
Sponsor
Chinese University of Hong Kong
Collaborators
MetaCure Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00975533
Brief Title
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

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong
Collaborators
MetaCure Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
type 2 diabetes mellitus, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tantalus
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.
Intervention Type
Device
Intervention Name(s)
Tantalus
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.
Primary Outcome Measure Information:
Title
changes in body weight before and after interventions at 6 and 12 months
Time Frame
6 months and 1 year
Title
changes in HbA1c before and after interventions
Time Frame
6 and 12 months
Title
frequency of hypoglycaemia
Time Frame
6 month and 1 year
Title
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
Title
composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia
Time Frame
6 month and 1 year
Secondary Outcome Measure Information:
Title
waist circumferences
Time Frame
6 month and 1 year
Title
insulin secretory responses (as measured by the standard meal test)
Time Frame
6 month and 1 year
Title
Hormonal profiles (including gut hormones)
Time Frame
6 months and 1 year
Title
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
Title
resting energy expenditure as monitored by indirect calorimetry (MedGem).
Time Frame
6 month and 1 year
Title
radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively)
Time Frame
6 months and 1 year
Title
differences in insulin requirement
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon KH Wong, MBChB
Phone
852-26322627
Email
wongkhmo@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon KH Wong, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon KH Wong, MBChB
First Name & Middle Initial & Last Name & Degree
Alice PS Kong, MBChB
First Name & Middle Initial & Last Name & Degree
Ronald CW Ma, MBChB
First Name & Middle Initial & Last Name & Degree
Juliana CN Chan, MBBS
First Name & Middle Initial & Last Name & Degree
Enders KW Ng, MBChB
First Name & Middle Initial & Last Name & Degree
Vannessa WS Ng, MBChB
First Name & Middle Initial & Last Name & Degree
Francis CC Chow, MBBS
First Name & Middle Initial & Last Name & Degree
Wing Yee So, MBChB
First Name & Middle Initial & Last Name & Degree
Winnie CW Chu, MBChB

12. IPD Sharing Statement

Citations:
PubMed Identifier
25710812
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.
Results Reference
derived

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

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