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

• ClinicalTrials.gov Identifier: NCT00975533
• Recruitment Status: Unknown
• First Posted: September 11, 2009
• Last Update Posted: September 11, 2009
• Sponsor: Chinese University of Hong Kong
• Collaborator: Metacure
• Information provided by: Chinese University of Hong Kong

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.

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

Study Design

• 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

Arms and Interventions

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

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

• 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

Contacts

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

Locations

China, Hong Kong

Prince of Wales Hospital

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Simon Kin-Hung WONG, The Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT00975533
• Other Study ID Numbers: CRE-2008.335
• First Posted: September 11, 2009
• 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; Hypoglycemic Agents; Physiological Effects of Drugs