UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Circulating Serpina3 / EGFR levels in type 2 diabetes patients before and after administering the GLP-1 receptor agonists.
Title of the study (Brief title)	Circulating Serpina3 / EGFR levels in type 2 diabetes patients before and after administering the GLP-1 receptor agonists.
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 evaluate the physiological significance of serum Serpina3 and EGFR in patients with type 2 diabetes before and after administering GLP-1 receptor agonist.
Basic objectives2	Others
Basic objectives -Others	To determine the physiological significance.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes in serum Serpina3 / EGFR levels in type 2 diabetes patients before and after administering the GLP-1 receptor agonists.
Key secondary outcomes	The association of metabolic parameters with the difference in serum Serpina3 / EGFR levels in type 2 diabetes patients between before and after administering GLP-1 receptor agonist.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients and inpatients with type 2 diabetes who fulfilled the following criteria. <GLP-1 receptor agonists group> 1) Age is over 20. 2) Patients diagnosed with type 2 diabetes. 3) Patients scheduled to start the treatment with GLP-1 receptor agonist. 4) Having provided voluntary written consent for participation in this study. <Control group (insulin group)> 1) Age is over 20. 2) Patients diagnosed with type 2 diabetes. 3) Patients scheduled to start the treatment with insulin injection. 4) Having provided voluntary written consent for participation in this study.
Key exclusion criteria	Patients corresponding to any of the following are inapplicable in the both GLP-1 receptor agonists group and control group. 1)Patients who ingest the DPP-4 inhibitors. 2)Patients with severe complications (liver disease, mental disorder, or cancer). 3)Patients with severe ketosis or diabetic coma. 4)Patients with severe infections, perioperative status, or severe trauma. 5)Patients whose baseline eGFR were <29 ml/min/1.73m^2. 6)Pregnancy or lactation in women. 7)Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size	20

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

Public contact
Name of contact person	Mayu Kyohara
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2016 Year 04 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 10 Day
Anticipated trial start date	2016 Year 04 Month 19 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cross-sectional study Recruitment of Subject: Outpatients and inpatients with type 2 diabetes in Yokohama City University hospital who fulfilled the inclusion/exclusion criteria. To evaluate the physiological significance of serum Serpina3 and EGFR in patients with type 2 diabetes before and after administering GLP-1 receptor agonist.

Management information
Registered date	2016 Year 04 Month 18 Day
Last modified on	2016 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025318