UMIN-CTR Clinical Trial

Basic information
Public title	Circulating Meteorin-like (Metrnl) levels in Japanese patients with type 2 diabetes.
Acronym	Circulating Meteorin-like (Metrnl) levels in Japanese patients with type 2 diabetes.
Scientific Title	Circulating Meteorin-like (Metrnl) levels in Japanese patients with type 2 diabetes.
Scientific Title:Acronym	Circulating Meteorin-like (Metrnl) levels in Japanese patients with type 2 diabetes.
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the role of serum Metrnl in the physiological significance in patients with type 2 diabetes
Basic objectives2	Others
Basic objectives -Others	To determine the physiological significance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum Metrnl levels
Key secondary outcomes	The association of the serum Metrnl levels with the various metabolic parameters is analyzed in enrolled subjects.

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	70 years-old >
Gender	Male and Female
Key inclusion criteria	<Type 2 diabetes group> Hospitalized Patients with type 2 diabetes who fulfilled the following criteria. 1) Age is over 20 and below 70. 2) Patients diagnosed with type 2 diabetes. 3) Having provided voluntary written consent for participation in this study. <Control group> Hospitalized Patients with non-type 2 diabetes who fulfilled the following criteria. 1) Age is over 20 and below 70. 2) Patients who are not diagnosed with type 2 diabetes. 3) Having provided voluntary written consent for participation in this study.
Key exclusion criteria	Patients corresponding to any of the following are inapplicable <Type 2 diabetes group> 1)Patients with severe complications( liver disease, mental disorder, cancer) 2)Patients with severe ketosis or diabetic coma. 3)Patients with severe infections, perioperative status, or severe trauma 4) Patients whose baseline eGFR were <29 ml/min/1.73m^2 5)Pregnancy or lactation in women 6) Patients who are judged by an investigator to be inappropriate for this study for any other reason. <Control group> 1)Patients with severe complications( liver disease, mental disorder, cancer) 2)Patients with severe infections, perioperative status, or severe trauma 3)Pregnancy or lactation in women 4) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Mayu Middle name Last name Kyohara
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	kyouhara-tym@umin.ac.jp

Sponsor
Institute	Yokohama City University hospital
Institute
Department

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	Yokohama City University hospital
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
Tel	045-787-2800
Email	kyouhara-tym@umin.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	2020 Year 06 Month 22 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	2016 Year 03 Month 31 Day
Date of IRB	2016 Year 05 Month 18 Day
Anticipated trial start date	2016 Year 05 Month 18 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cross-sectional study Recruitment of Subject: Hospitalized Patients with type 2 diabetes or non-type2 diabetes in Yokohama City University hospital who fulfilled the inclusion/exclusion criteria. To determine the role of serum Metrnl in the physiological significance in patients with type 2 diabetes

Management information
Registered date	2020 Year 06 Month 21 Day
Last modified on	2020 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046631