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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013092
Receipt No. R000014105
Scientific Title Risk factors for nocturnal hypertension including Sleep Apnea Syndromes (SAS) and diabetic autonomic neuropathy in patients with type 2 diabetes.
Date of disclosure of the study information 2014/02/06
Last modified on 2014/02/06

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Basic information
Public title Risk factors for nocturnal hypertension including Sleep Apnea Syndromes (SAS) and diabetic autonomic neuropathy in patients with type 2 diabetes.
Acronym Risk factors for nocturnal hypertension in type 2 diabetes.
Scientific Title Risk factors for nocturnal hypertension including Sleep Apnea Syndromes (SAS) and diabetic autonomic neuropathy in patients with type 2 diabetes.
Scientific Title:Acronym Risk factors for nocturnal hypertension in type 2 diabetes.
Region
Japan

Condition
Condition Diabetes mellitus type 2
Hypertension
Classification by specialty
Medicine in general Cardiology Pneumology
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the prevalence, severity and risk factors of the nocturnal hypertension in type 2 diabetic patients.
Basic objectives2 Others
Basic objectives -Others Diagnostic
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diurnal variation in blood pressure, morning blood pressure surge.
Key secondary outcomes Mean blood pressure, short-term blood pressure variability

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) Type 2 diabetic inpatients with hypertension.
2) Those who can understand the instruction and agree on the written consent.
Key exclusion criteria 1) Patients with stroke.
2) Patients with heart failure.
3) Patients with chronic kidney disease(G4 or more severe).
4) Patients with dementia or depression.
5) Patients with CPAP treatment.
6) Patients with frequent PACs, PVCs or atrial fibrillation.
7) Patients with type 1 diabetes.
8) Patients with serious infection, inflammation, or injury, preoperative or postoperative state.
9) Heavy alcohol drinker (patients who drink more than 480 mL of Japanese Sake, 2L of beer, 180 mL of whisky, 360 mL of wine or 360 mL of Shochu per day).
10) Patients who are pregnant, hope to be pregnant, or are in lactation period.
11) Patients who are not applicable to this study judged by the medical doctor.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasumichi Mori MD PhD
Organization Toranomon Hospital.
Division name Department of Endocrinology and Metabolism.
Zip code
Address 2-2-2 Toranomon Minato ward, Tokyo, 105-8470, Japan
TEL 03-3588-1111
Email ymori-metab@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Nishimura MD
Organization Toranomon Hospital
Division name Department of Endocrinology and Metabolism.
Zip code
Address 2-2-2 Toranomon Minato ward, Tokyo, 105-8470, Japan
TEL 03-3588-1111
Homepage URL
Email toranishi@gmail.com

Sponsor
Institute Toranomon Hospital Department of Endocrinology and Metabolism.
Institute
Department

Funding Source
Organization Okinaka Memorial Institute for Medical Research.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2014 Year 02 Month 06 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 Enrolling by invitation
Date of protocol fixation
2013 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ABPM
mean and standard deviation of blood pressure in 24 hr, daytime and nighttime
diurnal blood pressure variation
mornig blood pressure surge
Laboratory data
HbA1c, GA, BG, RBC, WBC, Hb, Ht, Plt, TG, TC, HDC-C, LDL-C, AST, ALT, gamma-GTP, ALP, LDH, T-Bil, BUN, Cre, UA, TP, Alb, CK, Na, K, Cl, hs-CRP, urinary qualitative examination, urinary protein, urinary microalbumin, urinary 8OHdG
Other examinations
ECG including coefficient of variation of RR intervals, baPWV, mean IMT, max IMT, sleep test, retinal photograph
Age, sex, bmi, diabetic complications, past history, medications, daily sodium intake, physical activity

Management information
Registered date
2014 Year 02 Month 06 Day
Last modified on
2014 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014105

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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