UMIN-CTR Clinical Trial

Public title

Circulating Serpina3 / EGFR levels in type 2 diabetes patients before and after administering the GLP-1 receptor agonists.

Acronym

Circulating Serpina3 / EGFR levels in type 2 diabetes patients before and after administering the GLP-1 receptor agonists.

Scientific Title

Circulating Serpina3 / EGFR levels in type 2 diabetes patients before and after administering the GLP-1 receptor agonists.

Scientific Title:Acronym

Circulating Serpina3 / EGFR levels in type 2 diabetes patients before and after administering the GLP-1 receptor agonists.

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Terauchi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Endocrinology and Metabolism

Zip code

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2800

Email

terauchi@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Mayu Kyohara

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Endocrinology and Metabolism

Zip code

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2800

Homepage URL

Email

kyouhara-tym@umin.ac.jp

Institute

Yokohama City University hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

03

Month

10

Day

Date of IRB

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

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.

Registered date

2016

Year

04

Month

18

Day

Last modified on

2016

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025318