UMIN ID: UMIN000001886
Registered date:14/04/2009
A multicenter observational study of clinical relevance of microalbuminuria and intra-renal RAS in type 2 diabetes.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 Diabetes Mellitus |
| Date of first enrollment | 2009/04/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 1) AGT (urine and serum): 0, 6, 12, 18, 24, 30 and 36 months 2) Albumin (urine): 0, 6, 12, 18, 24, 30 and 36 months |
|---|---|
| Secondary Outcome | 1) BP: 0, 6, 12, 18, 24, 30 and 36 months 2) BW, BMI, waist circumference:0, 6, 12, 18, 24, 30 and 36 months 3) FBS, insulin, HbA1c: 0, 6, 12, 18, 24, 30 and 36 months 4) PRA, Aldosterone: 0, 12, 24 and 36 months 5) T-chol, LDL-chol, HDL-chol, TG: 0, 12, 24 and 36 months 6) Cr, BUN, UA: 0, 6, 12, 18, 24, 30 and 36 months 7) Transferrin, type IV collagen (urine): 0, 6, 12, 18, 24, 30 and 36 months 8) Cardiovascular events: 0-36 months 9) Insulin sensitivity: 0, 12, 24 and 36 months 10) hsCRP: 0, 12, 24 and 36 months |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Type 1 diabetes mellitus 2) Pregnancy 3) Severe renal disease (Proteinuria, CCr<50 mL/min, sCr >= 1.5 mg/dL) 4) Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU) 5) Endocrine disease 6) Patients with malignant tumor 7) Patients inadequate for the study |
Related Information
| Primary Sponsor | Kagawa University, Faculty of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hirofumi Hitomi |
| Address | 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan Japan |
| Telephone | 087-891-5111 |
| hitomi@kms.ac.jp | |
| Affiliation | Kagawa University, Faculty of Medicine Department of Pharmacology |
| scientific contact | |
| Name | Toshihiko Ishida |
| Address | 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan Japan |
| Telephone | 087-891-5111 |
| Affiliation | Kagawa University, Faculty of Medicine Division of Hematology, Endocrinology and Metabolism, Department of Internal Medicine |