UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041917 |
|---|---|
| Receipt number | R000047827 |
| Scientific Title | A study on immune cell exhaustion in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/09/28 16:25:28 |
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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
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
isaousui@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047827
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