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) studied | preclinical Cushing's syndrome |
| Date of first enrollment | 2006/09/01 |
| Target sample size | 1000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | To elucidate the prevalence of preclinical Cushing's syndrome in Japanese Type 2 diabetic patients |
|---|---|
| Secondary Outcome | To elucidate the prognosis of the preclinical Cushing's syndrome and its interrelationship with obesity, hypertension, and hyperlipidemia |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | National Hospital Organization, Kyoto Medical Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | National Hospital Organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Mitsuhide Naruse |
| Address | 1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, Japan Japan |
| Telephone | 075-641-9164 |
| mnaruse@kyotolan.hosp.go.jp | |
| 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 |