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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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ClinicalTrials.gov Identifier: NCT00975533
Recruitment Status : Unknown
Verified September 2009 by Chinese University of Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2009
Last Update Posted : September 11, 2009
Sponsor:
Collaborator:
Metacure
Information provided by:
Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 10, 2009
First Posted Date  ICMJE September 11, 2009
Last Update Posted Date September 11, 2009
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
  • 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). [ 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Tantalus
  • 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.
    Intervention: Drug: Insulin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 10, 2009)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00975533
Other Study ID Numbers  ICMJE CRE-2008.335
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Simon Kin-Hung WONG, The Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Metacure
Investigators  ICMJE
Principal Investigator: Simon KH Wong, MBChB Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP