- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00975533
Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial
September 10, 2009 updated by: Chinese University of Hong Kong
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.
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Simon KH Wong, MBChB
- Phone Number: 852-26322627
- Email: wongkhmo@cuhk.edu.hk
Study Locations
-
-
Hong Kong
-
Shatin, Hong Kong, China
- Prince of Wales Hospital
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Principal Investigator:
- Simon KH Wong, MBChB
-
Sub-Investigator:
- Alice PS Kong, MBChB
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Sub-Investigator:
- Ronald CW Ma, MBChB
-
Sub-Investigator:
- Juliana CN Chan, MBBS
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Sub-Investigator:
- Enders KW Ng, MBChB
-
Sub-Investigator:
- Vannessa WS Ng, MBChB
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Sub-Investigator:
- Francis CC Chow, MBBS
-
Sub-Investigator:
- Wing Yee So, MBChB
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Sub-Investigator:
- Winnie CW Chu, MBChB
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
The device is intended to improve glycemic control and induce weight loss.
|
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.
|
Active Comparator: Control
Insulin treatment will be prescribed, in accordance with the common medical practice at the institute.
Dosages will be recorded on a daily basis.
|
Insulin treatment will be prescribed, in accordance with the common medical practice at the institute.
Dosages will be recorded on a daily basis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in body weight before and after interventions at 6 and 12 months
Time Frame: 6 months and 1 year
|
6 months and 1 year
|
changes in HbA1c before and after interventions
Time Frame: 6 and 12 months
|
6 and 12 months
|
frequency of hypoglycaemia
Time Frame: 6 month and 1 year
|
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
|
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
|
6 month and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
waist circumferences
Time Frame: 6 month and 1 year
|
6 month and 1 year
|
insulin secretory responses (as measured by the standard meal test)
Time Frame: 6 month and 1 year
|
6 month and 1 year
|
Hormonal profiles (including gut hormones)
Time Frame: 6 months and 1 year
|
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
|
6 month and 1 year
|
resting energy expenditure as monitored by indirect calorimetry (MedGem).
Time Frame: 6 month and 1 year
|
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
|
6 months and 1 year
|
differences in insulin requirement
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Simon KH Wong, MBChB, Chinese University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Anticipated)
July 1, 2011
Study Completion (Anticipated)
October 1, 2011
Study Registration Dates
First Submitted
September 10, 2009
First Submitted That Met QC Criteria
September 10, 2009
First Posted (Estimate)
September 11, 2009
Study Record Updates
Last Update Posted (Estimate)
September 11, 2009
Last Update Submitted That Met QC Criteria
September 10, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2008.335
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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