UMIN-CTR Clinical Trial

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

Diabetes mellitus type 2
Hypertension

Classification by specialty

Medicine in general	Cardiology	Pneumology
Endocrinology and Metabolism	Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Diurnal variation in blood pressure, morning blood pressure surge.

Key secondary outcomes

Mean blood pressure, short-term blood pressure variability

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Toranomon Hospital Department of Endocrinology and Metabolism.

Institute

Department

Personal name

Organization

Okinaka Memorial Institute for Medical Research.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

02

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2014

Year

02

Month

06

Day

Last modified on

2014

Year

02

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014105