UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055459 |
|---|---|
| Receipt number | R000063364 |
| Scientific Title | The study for association between peripheral vasoconstrictor response and myocardial diastolic dysfunction in patients with type 2 diabetes |
| Date of disclosure of the study information | 2024/09/09 |
| Last modified on | 2025/09/10 15:34:44 |
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Basic information
Public title
The study for association between peripheral vasoconstrictor response and myocardial diastolic dysfunction in patients with type 2 diabetes
Acronym
Association between peripheral vasoconstrictor response and myocardial diastolic dysfunction in patients with type 2 diabetes
Scientific Title
The study for association between peripheral vasoconstrictor response and myocardial diastolic dysfunction in patients with type 2 diabetes
Scientific Title:Acronym
Association between peripheral vasoconstrictor response and myocardial diastolic dysfunction 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
The purpose of this study is to determine the relationship between peripheral vasoconstrictor response and myocardial diastolic dysfunction, and to establish a method to predict early myocardial diastolic dysfunction in patients with type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
Another purpose of this study is to measure fragmented QRS (fQRS), which may be a predictor of myocardial diastolic dysfunction in electrocardiograms, and also to determine its relationship with peripheral vasoconstrictor response and various parameters in patients with type 2 diabetes.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between index of myocardial diastolic dysfunction and peripheral vasoconstrictor response.
Key secondary outcomes
Correlation of diabetic neuropathy parameters (CVR-R, Schellong test, nerve conduction velocity test, etc.) with myocardial diastolic dysfunction and other cardiac function parameters (BNP, left ventricular ejection fraction, fQRS, etc.).
Correlation of cardiac function parameters with clinical indicators of diabetic complications (retinopathy stage, urinary albumin, eGFR, etc.).
Blood test: NT-proBNP, high-sensitivity CRP, TNF-alpha, IL-6, total PAI-1, Renin, Aldosterone, Adrenaline, Noradrenaline, Dopamine, Eotaxin, HMW (high molecular weight)-adiponectin, MLC (myosin light chain)-1, etc.
Vascular endothelial function test: End-PAT
Peripheral vasoconstriction response: laser doppler flowmetry
Electrocardiography: fQRS, CVR-R, etc.
Evaluation of peripheral arterial disease: ABI (ankle brachial index)
Echocardiography: GLS, E/e, E/A, DcT, etc.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients (male or female) between 18 and under 80 years old
2) Inpatients with type 2 diabetes
3) Patients giving consent in writing for participation for this study
Key exclusion criteria
1) Patients with type 1 diabetes, or diabetes caused by other specific mechanistic diseases
2) Patients with diabetes during pregnancy
3) Patients hospitalized due to acute complications of diabetes (DKA, HHS, hypoglycemia, etc.)
4) Patients hospitalized for acute infectious diseases (pneumonia, cellulitis, etc.)
5) Patients hospitalized for cardiovascular diseases (ACS, Af, etc.)
6) Patients with a history of catheterization for cardiovascular diseases within 1 year
7) Patients with a left ventricular ejection fraction (EF) of 40% or less
8) Patients with heart failure symptoms or anginal pain in the resting state
9) Patients on oral beta-blockers
10) Patients with an ABI (ankle brachial pressure index) of less than 0.9
11) Patients with severe hepatic dysfunction
12) Patients with neurological disease presenting with autonomic neuropathy
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Sakurai |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu, Tochigi, Japan
TEL
028-287-2150
ssakurai@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Sakurai |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu, Tochigi, Japan
TEL
028-287-2150
Homepage URL
ssakurai@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
Clinical Research Management Center, Dokkyo Medical University
Address
880 Kita-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
| 2024 | Year | 09 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross sectional study
Management information
Registered date
| 2024 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063364
