UMIN-CTR Clinical Trial

Basic information
Public title	A study on immune cell exhaustion in patients with type 2 diabetes
Acronym	Immune cell exhaustion in type 2 diabetes patients
Scientific Title	A study on immune cell exhaustion in patients with type 2 diabetes
Scientific Title:Acronym	Immune cell exhaustion in type 2 diabetes patients
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the involvment of T lymphocyte exhaustion in the weakened immunity in patients with type 2 diabetes
Basic objectives2	Others
Basic objectives -Others	To evaluate the expression of co-inhibitors in type 2 diabetes patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the expression levels of co-inhibitors on peripheral blood T lymphocytes between type 2 diabetes and non-diabetic patients
Key secondary outcomes	To compare the expression levels of co-inhibitors on peripheral blood T lymphocytes before and after the improvement of blood glucose level in type 2 diabetes patients

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	65 years-old >
Gender	Male and Female
Key inclusion criteria	A. diabetes group: 1) hospitalized patients with type 2 diabetes 2) HbA1c>8.5% 3) fasting plasma glucose >160 mg/dL or postprandial plasma glucose >250 mg/dL B. non-diabetic group: 1) HbA1c<6.0% and fasting plasma glocose <110 mg/dL 2) no past history of diabetes mellitus
Key exclusion criteria	1) patients with active chronic infectious diseases such as tuberculosis 2) patients with acute infectious diseases such as pneumonia 3) patients with history of chronic inflammatorys diseases such as rheumatoid arthritis 4) patients with history of cancer 5) immunodeficient patients such as those with AIDS 6) patients taking immunosuppressant, steroids, and anti-cancer drugs 7) pregnant, potentially pregnant or lactating women 8) patients with moderate renal dysfunction (male serum creatinin 1.3 mg/dL or higher, female 1.2 mg/dL or higher)
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Usui
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
Zip code	321-0293
Address	880 Kita-Kobayashi Mibu-machi Shimotsuga-gun Tochigi
TEL	0282-87-2150
Email	isaousui@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Usui
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
Zip code	321-0293
Address	880 Kita-Kobayashi Mibu-machi Shimotsuga-gun Tochigi
TEL	0282-87-2150
Homepage URL
Email	isaousui@dokkyomed.ac.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
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	Dokkyo Medical University
Address	880 Kita-Kobayashi Mibu-machi Shimotsuga-gun Tochigi
Tel	0282-87-2150
Email	isaousui@dokkyomed.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 10 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 07 Month 11 Day
Date of IRB	2020 Year 08 Month 11 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We will analyze T lymphocyte function including co-inhibitors in 30 tyep 2 diabetes patients who were hospitalized for a purpose of treating hyperglycemia. As a normal control, the same analysis will be performed in 30 patients hospitalizd for the treatment of diseases other than diabetes. For the diabetes patients, the same items will be measured not only at admission but also at discharge with the improvement of hyperglycemia.

Management information
Registered date	2020 Year 09 Month 28 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047827

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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