UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028120 |
|---|---|
| Receipt number | R000032180 |
| Scientific Title | Clarification of pathophysiological roles of salusin-beta and salusion-beta-related peptides in lifestyle-related diseases. |
| Date of disclosure of the study information | 2017/07/10 |
| Last modified on | 2021/06/01 00:05:00 |
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Basic information
Public title
Clarification of pathophysiological roles of salusin-beta and salusion-beta-related peptides in lifestyle-related diseases.
Acronym
Clarification of pathophysiological roles of salusin-beta in lifestyle-related diseases.
Scientific Title
Clarification of pathophysiological roles of salusin-beta and salusion-beta-related peptides in lifestyle-related diseases.
Scientific Title:Acronym
Clarification of pathophysiological roles of salusin-beta in lifestyle-related diseases.
Region
| Japan |
Condition
Condition
Diabetes mellitus, hypertension and dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify pathophysiological roles of salusin-beta and salusin-beta-related peptides in patients with lifestyle-related diseases, such as diabetes, hypertension and lipid disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma levels of salusin-beta and salusin-beta-related peptides.
Key secondary outcomes
1. Clinical characteristics: age, height, weight, lifestyle, duration of morbidity
2. Blood pressure, heart rate
3. Blood tests: plasma glucose, HbA1c, glycated albumin, 1.5-AG, total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, free fatty acid, the other biochemical measurements, complete blood count.
4. Urine tests: urine protein, urine sugar, urine blood, urine albumin/creatinine ratio
5. Insulin secretory capacity (diabetic subjects): immunoreactive insulin, C-peptide, urine C-peptide, glucagon
6. Glucose profiles by continuous glucose monitoring (diabetic subjects)
7. Endocrine examinations
(1)Diabetic subjects: oral glucose tolerance test, meal tolerance test, glucagon tolerance test
(2)Subjects with hypertension: captopril challenge test, furosemide-upright test, rapid ACTH test, over-night dexamethasone test
8. Diabetic complication and arteriosclerosis
1) Diabetic neuropathy (diabetic subjects): symptoms by diabetic neuropathy, Achilles tender reflex, limbs vibration tests
2) Diabetic nephropathy (diabetic subjects): urine albumin/creatinine ratio, urine protein, eGFR
3) Diabetic retinopathy (diabetic subjects): examination by Ophthalmologist
4) arteriosclerosis (subjects with lifestyle-related diseases)
(1)Ischemic heart disease, cerebral arterial disease, peripheral arterial disease
(2)Electrocardiogram, chest and abdominal X-ray, Holter ECG, cervical arterial echography, ankle-brachial pressure index, pulse wave velocity, limbs arterial echography
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who fulfills more than one of the diagnostic criteria of diabetes, hypertension and lipid disorder. Or healthy volunteer.
2. Subjects who has been signed the consent form after sufficiently informed and fully understood this study.
Key exclusion criteria
1. Patient with vert infectious diseases
2. Patient with overt malignant tumor
3. Pregnancy
4. Subject whom director of this study disqualified
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Shichiri |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8706
shichiri@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8706
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine
Address
1-15-1 Kitasato, Minami-ku, Sagamihara
Tel
0427788111
rinrib@med.kitasato-u.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
| 2017 | Year | 07 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Prospective observational study, which examines associations between salusin and salusin-related peptides, and complications caused by lifestyle-related diseases.
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032180
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
