UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000667 |
|---|---|
| Receipt number | 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 23:06:08 |
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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
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
uchinok@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000802
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