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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000453
Receipt No. R000000549
Scientific Title Preclinical Cushing's syndrome in diabetes mellitus of Japan
Date of disclosure of the study information 2006/08/01
Last modified on 2010/04/01

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Basic information
Public title Preclinical Cushing's syndrome in diabetes mellitus of Japan
Acronym PCUJ study
Scientific Title Preclinical Cushing's syndrome in diabetes mellitus of Japan
Scientific Title:Acronym PCUJ study
Region
Japan

Condition
Condition preclinical Cushing's syndrome
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of the prevalence of preclinical Cushing's syndrome in Japanese Type 2 diabetic patients
Basic objectives2 Others
Basic objectives -Others Prevalence
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To elucidate the prevalence of preclinical Cushing's syndrome in Japanese Type 2 diabetic patients
Key secondary outcomes To elucidate the prognosis of the preclinical Cushing's syndrome and its interrelationship with obesity, hypertension, and hyperlipidemia

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
80 years-old >=
Gender Male and Female
Key inclusion criteria Outpatient or admitted patients with type 2 diabetes according to the criteria of the Japan Diabetes Society are recruited to the study.
Key exclusion criteria 1. Patients with overt signs or symptoms of Cushing's syndrome, including moon face, buffalo hump, central obesity, striae cutis, etc.

2. Patients under the treatment of glucocorticoids or with the history of long-term glucocorticoid therapy over six months.

3. Patients with type 1 diabetes mellitus, gestational diabetes mellitus, and other secondary diabetes.

4. Patients with conditions or illness described below;

4-1. Conditions or illness with possible alteration of ACTH-cortisol secretion, including
-chronic alcoholism
-sleep apnea syndrome
-poorly controlled diabetes(HbA1c>=10.0%)
-irregular life style with altered sleep-awake cycle

4-2. Unstable and/or severe illness considered to be not suitable for the study, including
-coronary heart disease(myocardial infarction, angina pectoris)
-arrhythmia
-severe valvular heart diseases
-hypertrophic cardiomyopathy
-congestive heart failure
-cerebrovascular disease(cerebral apoplexy, transient ischemic attack)
-acute or chronic renal failure(serum Cr>=3mg/dl)
-acute or chronic liver disease (moderate to severe)
-asymptomatic hypoglycemia
-active stage of peptic ulcer

5. Patients under the treatment of drugs such as phenobarbital, rifampicin, carbamazepine, phenytoin, ephedrine, and macrolide antibiotics, which can alter the effect of dexamethasone.

6. Other various conditions if the attending physician make decision not suitable for the study.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makito Tanabe
Organization National Hospital Organization Kokura Hospital
Division name Department of clinical research
Zip code
Address 10-1 Harugaoka, Kokuraminami-ku, Kitakyushu 802-8533, Japan
TEL 093-921-8881
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, Japan
TEL 075-641-9164
Homepage URL
Email mnaruse@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization, Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
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
2006 Year 08 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 Completed
Date of protocol fixation
2006 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2006 Year 09 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 05 Month 01 Day
Date trial data considered complete
2008 Year 07 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information Previous foreign reports described that the prevalence of preclinical Cushing's syndrome in type 2 diabetes was 3.3-9.4%.

Management information
Registered date
2006 Year 07 Month 24 Day
Last modified on
2010 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000549

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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