A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes.

UMIN ID: UMIN000001887

Registered date:14/04/2009

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: 160
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Telmisartan (20-80 mg/day, 12 months)

Outcome(s)

• Primary Outcome: 1) AGT (urine and serum): 0, 6 and 12 months 2) Albumin (urine): 0, 6 and 12 months
• Secondary Outcome: 1) BP: 0, 2, 4, 6, 8, 10 and 12 months 2) BW, BMI, waist circumference:0, 6 and 12 months 3) FBS, insulin, HbA1c: 0, 6 and 12 months 4) PRA, Aldosterone: 0 and 12 months 5) T-chol, LDL-chol, HDL-chol, TG: 0 and 12 months 6) Cr, BUN, UA: 0, 6 and 12 months 7) Cardiovascular events: 0-12 months 8) Insulin sensitivity: 0, 6 and 12 months 9) hsCRP: 0, 6 and 12 months

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Type 1 diabetes mellitus 2) Pregnancy 3) Severe renal disease (CCr<30 mL/min, sCr >= 2.0 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
• Source(s) of Monetary Support: None