UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040631 |
|---|---|
| Receipt number | R000046344 |
| Scientific Title | Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy |
| Date of disclosure of the study information | 2020/06/02 |
| Last modified on | 2020/06/02 18:22:08 |
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Basic information
Public title
Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes
Acronym
Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy
Scientific Title
Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy
Scientific Title:Acronym
Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we targeted patients with type 2 diabetes by measuring CCL11 (eotaxin) and CCL22 (MDC), one of the chemokines, and IL-6 and IL-18, which are one of the cytokines. The purpose of this study is to analyze the clinical significance of the three major complications of patients with diabetic neuropathy, insulin resistance, arteriosclerosis, and other blood sampling . In addition, urinary metabolomics and urinary NGAL are measured, the relationship with diabetic neuropathy is considered, and the aim is to search for new clinical markers that are considered necessary for future treatment of diabetic neuropathy.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to analyze the clinical significance of the three major complications mainly of diabetic neuropathy, insulin resistance, arteriosclerosis, and various blood sampling items in type 2 diabetic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical significance of serum chemokine levels in patient with diabetes and diabetic neuropathy.
Key secondary outcomes
Time of measurement: early in the morning, fasting
Measurement items (LSI): CCL11 (eotaxin) CCL22 (MDC)
IL-6 IL-18
Urine Metabolomics
U-NGAL
serum: FGF21 BDNF HMW adiponectin IL-33s TNF-R1 & -R2
Relationship with diabetic complications: peripheral neuropathy: staging, nerve conduction test, CVR-R
Orthostatic hypotension (Sheron test)
Timed up and Go test, Monofilament
Nephropathy: eGFR UAE
Retinopathy: Stage
Relationship with insulin resistance: BMI, InBody, DualScan
Relationship with arteriosclerosis: CAVI / ABI FMD carotid IMT
Routine examination at admission + IgE + TARC + Beta-hydroxyl-butyrate + M2BPG (i Mac-2 binding protein sugar chain modification isomer), Ca, P, active Vitamin D3
Heart rate variability (HRV): CVR-R, power spectrum analysis (PSA)
The severity of diabetic kidney disease
Coagulation fibrinolysis system: vWF, d dimer, etc.
Arterial stiffness: PWV, CAVI
abdominal echo
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 6.5 and 12.0%) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed
Key exclusion criteria
1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)Patient with intolerance of medical reasons by doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Jojima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0828-87-2150
jojima@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Teruo |
| Middle name | |
| Last name | Jojima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0282-87-2150
Homepage URL
jojima@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
880kita-kobayashi,Mibu,Tochigi,Japan
Tel
0282-87-2275
r-kenkyu@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 | 06 | Month | 02 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross section study
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046344
