UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Short term MET effects on insulin resistance in type 2 diabetes mellitus.
Title of the study (Brief title)	Short term MET effects on insulin resistance in T2DM
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the acute effect of MET on insulin resistance measured by hyperinsulinemic euglycemic glucose clamp.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	glucose infusion rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	MET treatment (1.4 V/cm, 0.1ms, 55 pps, 42 degrees) for 60min.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	Type 2 diabetes mellitus (T2DM) i)Abdominal obesity, given as waist circumference greater than 85 cm ii)HbA1c more than 6.9%, less than 10.5% (NGSP)
Key exclusion criteria	i) Past history or current medication of myocardial infarction, angina, apoplexy and arteriosclerosis obliterans. ii)Severe wound, infections, pre- or post-operation. iii)Severe liver dysfunction (GOT and/or GPT: greater than 100U). iv)Chronic heart failure, familial dyslipidemia. v)Severe diabetic complications. vi)Pacemaker carrier.
Target sample size	5

Research contact person
Name of lead principal investigator	Eiichi Araki
Organization	Kumamoto University, Faculty of Life Sciences.
Division name	Metabolic Medicine
Address	1-1-1 Honjo, Kumamoto
TEL	096-373-5169
Email	earaki@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person	Tatsuya Kondo
Organization	Kumamoto University, Faculty of Life Sciences.
Division name	Metabolic Medicine
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5169
Homepage URL
Email	t-kondo@gpo.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University, Faculty of Life Sciences, Metabolic Medicine
Institute
Department

Funding Source
Organization	Kumamoto University, Faculty of Life Sciences, Metabolic Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 04 Month 17 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2013 Year 03 Month 01 Day
Date trial data considered complete	2013 Year 05 Month 01 Day
Date analysis concluded	2013 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 20 Day
Last modified on	2018 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009186