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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2009 by Chinese University of Hong Kong.
Recruitment status was: Not yet recruiting

Sponsor:

Collaborator:

Metacure

Information provided by:

Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00975533

First received: September 10, 2009

Last updated: NA

Last verified: September 2009

History: No changes posted

Purpose

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	Intervention	Phase
Type 2 Diabetes Mellitus	Device: Tantalus Drug: Insulin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	24
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 History of Changes
Other Study ID Numbers:	CRE-2008.335
Study First Received:	September 10, 2009
Last Updated:	September 10, 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

ClinicalTrials.gov processed this record on June 29, 2017

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