NIPH Clinical Trials Search

UMIN ID: C000000453

Registered date:01/08/2006

Preclinical Cushing's syndrome in diabetes mellitus of Japan

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpreclinical Cushing's syndrome
Date of first enrollment2006/09/01
Target sample size1000
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeTo elucidate the prevalence of preclinical Cushing's syndrome in Japanese Type 2 diabetic patients
Secondary OutcomeTo elucidate the prognosis of the preclinical Cushing's syndrome and its interrelationship with obesity, hypertension, and hyperlipidemia

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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.

Related Information


public contact
Name Mitsuhide Naruse
Address 1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, Japan Japan
Telephone 075-641-9164
Affiliation National Hospital Organization, Kyoto Medical Center Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
scientific contact
Name Makito Tanabe
Address 10-1 Harugaoka, Kokuraminami-ku, Kitakyushu 802-8533, Japan Japan
Telephone 093-921-8881
Affiliation National Hospital Organization Kokura Hospital Department of clinical research