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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000667
Receipt No. R000000802
Scientific Title Effects of renal dysfunction and sleep apnea on ambulatory blood pressure profile, cardiovascular function, and glucose and lipid metabolism: cross-sectional and prognosis study.
Date of disclosure of the study information 2008/11/01
Last modified on 2015/09/21

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Basic information
Public title Effects of renal dysfunction and sleep apnea on ambulatory blood pressure profile, cardiovascular function, and glucose and lipid metabolism: cross-sectional and prognosis study.
Acronym Effects of renal dysfunction and sleep apnea on ambulatory blood pressure profile, cardiovascular function, and glucose and lipid metabolism: cross-sectional and prognosis study.
Scientific Title Effects of renal dysfunction and sleep apnea on ambulatory blood pressure profile, cardiovascular function, and glucose and lipid metabolism: cross-sectional and prognosis study.
Scientific Title:Acronym Effects of renal dysfunction and sleep apnea on ambulatory blood pressure profile, cardiovascular function, and glucose and lipid metabolism: cross-sectional and prognosis study.
Region
Japan

Condition
Condition Hypertensionj
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1
The aim of this study was to examine possible effects of renal dysfunction and sleep apnea on ambulatory blood pressure profile, cardiovascular function, and glucose and lipid metabolism by cross-sectional and prognosis study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) casual blood pressure
2) ambulatory blood pressure monitoring
3) sleep apnea test
4) renal function: creatinine clearance by Cockcroft-Gault formula
5) glucose metabolism: fasting blood glucose, fasting IRI, HOMA-IR
6) lipid metabolism: total cholesterol, LDL, HDL, TG, adiponectin
7) cardiac function: ANP, BNP, UCG
8) vascular function: ABI/BWV, carotid echogram
9) sympathetic nerve activity and renin-angiotensin system
10) inflammatory and oxidative markers: CRP, fibrinogen, MDA-LDL, AGE.
Key secondary outcomes

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 Blood pressure >= 130/80
Key exclusion criteria acute myocardial infarction, collagen disease, acute renal failure
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi TAMURA
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Email tamukou@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazukai Uchino
Organization Yokohama City University School of Medicine
Division name Department of Medical Science
Zip code
Address 3-9 Fukuura, Kanazawa-ku
TEL 045-787-2634
Homepage URL
Email uchinok@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
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
Address
Tel
Email

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
2008 Year 11 Month 01 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
2005 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2020 Year 03 Month 01 Day
Date trial data considered complete
2021 Year 03 Month 01 Day
Date analysis concluded
2022 Year 03 Month 01 Day

Other
Other related information Ambulatory blood pressure (BP) monitoring allows the acquisition of information not only on the average 24-h BP, but also on the variations that characterize BP values in the course of daily life. Ambulatory BP monitoring has also allowed an easier and more accurate determination of the circadian rhythm of BP under different pathological conditions, and has enabled to evaluate the effects of antihypertensive drugs (Mancia G, Parati G. Ambulatory blood pressure monitoring and organ damage. Hypertension 2000: 36: 894-900; Imai Y. Prognostic significance of ambulatory blood pressure. Blood Press Monit 1999: 4: 249-256).
Ambulatory BP monitoring has allowed an easier and more accurate determination of the circadian rhythm of BP under different pathophysiological conditions. This circadian pattern of BP in patients with diabetes has been found to have a blunted nocturnal dipping in BP, which is associated with autonomic neuropathy and nephropathy. The loss of nocturnal dipping in BP has been considered to be a risk factor for the progression of nephropathy itself, and to be of prognostic value with respect to target organ damage and cardiovascular morbidity in both diabetic and hypertensive patients. However, the factors involved in the BP variability observed in diabetic patients are not elucidated and may themselves play an independent role in the cardiovascular complications in diabetic patients. More and better evidence on BP variability could lead to a more precise understanding of the pathogenesis of hypertension with diabetes.
In this study we will examine possible effects of renal dysfunction and sleep apnea on ambulatory blood pressure profile, cardiovascular function, and glucose and lipid metabolism by cross-sectional and prognosis study.

Management information
Registered date
2007 Year 04 Month 02 Day
Last modified on
2015 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000802

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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