UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008367 |
|---|---|
| Receipt number | R000009823 |
| Scientific Title | Establishment of organ specific insulin resistance indices in lifestyle-related diseases |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2022/01/12 16:12:57 |
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Basic information
Public title
Establishment of organ specific insulin resistance indices in lifestyle-related diseases
Acronym
Euglycemic hyperinsulinemic clamp with stable isotope tracer infusion
Scientific Title
Establishment of organ specific insulin resistance indices in lifestyle-related diseases
Scientific Title:Acronym
Euglycemic hyperinsulinemic clamp with stable isotope tracer infusion
Region
| Japan |
Condition
Condition
Lifestyle-related diseases
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine organ specific insulin resistance in patient with lifestyle-related diseases and to establish simple insulin resistance indices.
Basic objectives2
Others
Basic objectives -Others
Validity
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hepatic and peripheral tissue insulin resistance (hepatic glucose production and insulin-stimulated glucose disposal)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Lifestyle-related diseases
Key exclusion criteria
1)Uncontrolled diabetes (HbA1c >10%)
2)Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg)
3)Pregnant or lactating women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | TAKAMURA |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Endocrinology and Metabolism
Zip code
920-8640
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2234
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Toshinari |
| Middle name | |
| Last name | Takamura |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Endocrinology and Metabolism
Zip code
920-8640
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2234
Homepage URL
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
Innovative clinical research center
Address
13-1 takaramachi kanazawa Ishikawa
Tel
(076)265-2100
t-isomu@adm.kanazawa-u.ac.jp
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 | 08 | Month | 01 | 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
In progress
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No adverse event
Management information
Registered date
| 2012 | Year | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009823
