UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007796 |
|---|---|
| Receipt number | R000009186 |
| Scientific Title | Short term MET effects on insulin resistance in type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2012/04/20 |
| Last modified on | 2018/04/25 09:15:34 |
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Basic information
Public title
Short term MET effects on insulin resistance in type 2 diabetes mellitus.
Acronym
Short term MET effects on insulin resistance in T2DM
Scientific Title
Short term MET effects on insulin resistance in type 2 diabetes mellitus.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Eiichi Araki |
Organization
Kumamoto University, Faculty of Life Sciences.
Division name
Metabolic Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5169
earaki@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kondo |
Organization
Kumamoto University, Faculty of Life Sciences.
Division name
Metabolic Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5169
Homepage URL
t-kondo@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University, Faculty of Life Sciences, Metabolic Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009186
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
