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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041917 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | type 2 diabetes | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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) |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |