UMIN-CTR Clinical Trial

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
Email	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
Email	ahayashi@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032180