UMIN ID: UMIN000000666
Registered date:01/11/2008
Effects of ARBs on ambulatory blood pressure, glucose and lipid metabolism, and autonomic nerve function in hypertensive diabetic nephropathy patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hypertension, type 2 diabetes, diabetic nephropathy |
| Date of first enrollment | 2005/01/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TL group: Start with once-daily dosing of telmisartan 40 mg, and dosage may be modulated accroding to the clinical parameters (telmisartan 20-80 mg/day). After 12 weeks telmisartan will be changed to losartan with once-daily dosing of 50 mg. Dosage may be modulated accroding to the clinical parameters (losartan 25-100 mg/day). LT group: Start with once-daily dosing of losartan 50 mg, and dosage may be modulated accroding to the clinical parameters (losartan 25-100 mg/day).. After 12 weeks losartan will be changed to telmisartan with once-daily dosing of 40 mg. Dosage may be modulated accroding to the clinical parameters (telmisartan 20-80 mg/day). |
Outcome(s)
| Primary Outcome | 1) Ambulatory blood pressure monitoring+: mean blood pressure, day-night variation, short-term blood pressure/heart rate variability, LF/HF 2) Renal function: creatinine clearance by Cockcroft-Gault method, urinary protein/albuminon excretion 3) Glucose metabolism: fasting blood glucose, fasting IRI, HOMA-IR. 4) Lipid metabolism: total cholesterol, LDL, HDL, MDA-LDA, oxidised cholesterol, small dense LDL, adiponectin. 5) Vascular function: ABI/baPWV, VEGF, HGF. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Pregnant women, or women suspected of being pregnant 2) Hyperkalemia 3) History of hypersensitivity to Telmisartan or Losartan 4) Severe liver disorder (losartan) 5) Severe biliary atresia or hepatic disorder (telmisartan) |
Related Information
| Primary Sponsor | Department of Cardiorenal Medicine, Yokohama City University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Cardiorenal Medicine, Yokohama City University School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuaki UCHINO |
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN Japan |
| Telephone | 045-787-2634 |
| uchinok@med.yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University School of Medicine Department of Medical Science |
| scientific contact | |
| Name | Kouichi TAMURA |
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN Japan |
| Telephone | 045-787-2635 |
| tamukou@med.yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University School of Medicine Department of Cardiorenal Medicine |