UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033791 |
|---|---|
| Receipt number | R000038427 |
| Scientific Title | The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder |
| Date of disclosure of the study information | 2018/08/17 |
| Last modified on | 2020/02/17 13:17:30 |
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Basic information
Public title
The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Acronym
The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Scientific Title
The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Scientific Title:Acronym
The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Region
| Japan |
Condition
Condition
endocrine and metabolic disorder
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of treatment on insulin sensitivity.
Basic objectives2
Others
Basic objectives -Others
To evaluate effects of treatment on insulin sensitivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline in organ specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study
Key secondary outcomes
1Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test
2Change from baseline in body composition
3Change from baseline in vital sign
4Change from baseline in hormone levels of endocrine and metabolic disorder
5Change from baseline in medication
6Change from baseline in liver function
7Changes from baseline in lipid profile
8Changes from baseline in renal function and electrolyte balance
9Changes from baseline in hepatokine levels
10Changes from baseline in oxidative and non-oxidative glucose disposal, respiratory quotients, and energy expenditure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who is diagnosed endocrinological disease
Patients whose content is obtained in written form
Key exclusion criteria
Younger than 20 years old
Pregnant or lactating women
Patient in endocrinological emergency
Severe mental problems not suitable for the study
Inability to participate in the study as assessed by the investigators.
Target sample size
100
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
920-8641
Address
13-1 Takara-machi Kanazawa Ishikawa
TEL
076-265-2234
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Yumie |
| Middle name | |
| Last name | Takeshita |
Organization
Kanazawa university hospital
Division name
Department of Endocrinology and metabolism
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2234
Homepage URL
takeshita@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa university hospital
Department of Endocrinology and metabolism
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kanazawa university
Address
13-1 Takara-machi
Tel
076-265-2110
rinri@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
| 2018 | Year | 08 | Month | 17 | 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
| 2018 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2018 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038427
