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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Tantalus Drug: Insulin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : October 2011

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Arms and Interventions
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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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. changes in body weight before and after interventions at 6 and 12 months [ Time Frame: 6 months and 1 year ]
  2. changes in HbA1c before and after interventions [ Time Frame: 6 and 12 months ]
  3. frequency of hypoglycaemia [ Time Frame: 6 month and 1 year ]
  4. 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 ]
  5. 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 Measures :
  1. waist circumferences [ Time Frame: 6 month and 1 year ]
  2. insulin secretory responses (as measured by the standard meal test) [ Time Frame: 6 month and 1 year ]
  3. Hormonal profiles (including gut hormones) [ Time Frame: 6 months and 1 year ]
  4. 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 ]
  5. resting energy expenditure as monitored by indirect calorimetry (MedGem). [ Time Frame: 6 month and 1 year ]
  6. radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively) [ Time Frame: 6 months and 1 year ]
  7. differences in insulin requirement [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975533


Contacts
Contact: Simon KH Wong, MBChB 852-26322627 wongkhmo@cuhk.edu.hk

Locations
China, Hong Kong
Prince of Wales Hospital Not yet recruiting
Shatin, Hong Kong, China
Principal Investigator: Simon KH Wong, MBChB         
Sub-Investigator: Alice PS Kong, MBChB         
Sub-Investigator: Ronald CW Ma, MBChB         
Sub-Investigator: Juliana CN Chan, MBBS         
Sub-Investigator: Enders KW Ng, MBChB         
Sub-Investigator: Vannessa WS Ng, MBChB         
Sub-Investigator: Francis CC Chow, MBBS         
Sub-Investigator: Wing Yee So, MBChB         
Sub-Investigator: Winnie CW Chu, MBChB         
Sponsors and Collaborators
Chinese University of Hong Kong
Metacure
Investigators
Principal Investigator: Simon KH Wong, MBChB Chinese University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Simon Kin-Hung WONG, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00975533     History of Changes
Other Study ID Numbers: CRE-2008.335
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: September 11, 2009
Last Verified: September 2009

Keywords provided by Chinese University of Hong Kong:
type 2 diabetes mellitus
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs