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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name