UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016382 |
|---|---|
| Receipt number | R000019028 |
| Scientific Title | Clinical analysis of the relations between serum zinc and testosterone in male patients with type 2 diabetes. |
| Date of disclosure of the study information | 2015/01/30 |
| Last modified on | 2015/01/30 07:43:04 |
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Basic information
Public title
Clinical analysis of the relations between serum zinc and testosterone in male patients with type 2 diabetes.
Acronym
Clinical analysis of the relations between serum zinc and testosterone in male patients with type 2 diabetes.
Scientific Title
Clinical analysis of the relations between serum zinc and testosterone in male patients with type 2 diabetes.
Scientific Title:Acronym
Clinical analysis of the relations between serum zinc and testosterone in male patients with type 2 diabetes.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relations between serum zinc and testosterone in male patients with type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
To investigate the relations between serum zinc and testosterone in male patients with type 2 diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relations between serum zinc and testosterone in male patients with type 2 diabetes.
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1) Patients with type 2 diabetes
2) Patients who were admitted between January 2014 and September 2014
Key exclusion criteria
1) Patients who have history of diabetic ketoacidosis, or diabetic coma in the past 6 months
2) Patients with serious infectious disease, before operation, serious trauma
4) Patients who receive steroid therapy
5) Patients with severe liver dysfunction
6) Patients who have history of pancreas disease
7) Patients who have history of cancer
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Eguchi |
Organization
Uwajima City Hospital
Division name
Department of Internal Medicine
Zip code
Address
Uwajima City Hospital, 1-1 Gotenmachi, Uwajima, Ehime, Japan
TEL
0895-25-1111
26016evian@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Eguchi |
Organization
Uwajima City Hospital
Division name
Department of Internal Medicine
Zip code
Address
Uwajima City Hospital, 1-1 Gotenmachi, Uwajima, Ehime, Japan
TEL
0895-25-1111
Homepage URL
26016evian@gmail.com
Sponsor or person
Institute
Uwajima City Hospital
Institute
Department
Personal name
Funding Source
Organization
Uwajima City Hospital
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
| 2015 | Year | 01 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)The relations between serum zinc and testosterone in male patients with type 2 diabetes
2)retrospective study
3)case-control study
Management information
Registered date
| 2015 | Year | 01 | Month | 30 | Day |
Last modified on
| 2015 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019028
