UMIN ID: UMIN000001959
Registered date:12/05/2009
Randomized multi-institutional study for effectiveness of intervention on life style in obese patients with fasting hyperglycemia or abnormal glucose tolerance test.
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Diabetes mellitus (Pre-diabetes ) |
| Date of first enrollment | 2004/05/01 |
| Target sample size | 600 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Frequent intervention: During three years, totally ten times of interview by medical doctors, guidance for life style by nurses and laboratory examinations such as fasting blood sugar, immuno-reactive insulin and fibronectin. Infrequent intervention: During three years, once-a-year performance of an interview by medical doctors, guidance for life style by nurses and laboratory examinations such as fasting blood sugar, immuno-reactive insulin and fibronectin per year. |
Outcome(s)
| Primary Outcome | incidence of diabetes mellitus |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 30years-old |
|---|---|
| Age maximum | 60years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) An individual who has a history of diabetes mellitus 2) An individual who is performing treatment for improvement of life style as food intake and physical exercise under the supervision of a medical doctor 3) An individual who has the following diseases or has a history of the following diseases (1) ischemic heart disease (2) cerebro-vascular disease (3) chronic hepatitis (4) liver cirrhosis (5) chronic pancreatitis (6) chronic nephritis (7) diseases of the pituitary gland (8) diseases of the thyroid gland (9) diseases of the adrenal gland (10) psychological impairment (11) status of post-gastrectomy (12) malignancy in an advanced stage 4) An individual who takes following drugs (1) steroid hormone (2) thyroid hormone (3) beta-blocker (4) diuretics 5) An individual who is judged as inappropriate for this study by a medical doctor |
Related Information
| Primary Sponsor | All Japan Federation of Social Insurance Associations |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | All Japan Federation of Social Insurance Associations |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Junko Nishida |
| Address | 3-22-1 Hyakunin-cho,Shinjuku-ku Tokyo, 169-0073, Japan Japan |
| Telephone | 03-3364-6216 |
| Affiliation | Chuou General Hospital of Social Insurance Department of Internal Medicine |
| scientific contact | |
| Name | Toshikazu Saito |
| Address | 3-22-1 Hyakunin-cho,Shinjuku-ku Tokyo, 169-0073, Japan Japan |
| Telephone | 03-3364-6216 |
| Affiliation | Chuou General Hospital of Social Insurance Department of Internal Medicine |