This trial is active, not recruiting.

Condition diabetic nephropathy
Sponsor National Taiwan University Hospital
Start date September 2010
Trial size 100 participants
Trial identifier NCT01273675, 201008056R


It is well understood that hypertension, dyslipidemia, and diabetes mellitus are the major risks of chronic kidney disease. Current guidelines recommend screening kidney estimated glomerular filtration function with serum creatinine. But it is not the utmost effective method and the GFR would be underestimated. Since good correlation was noticed between serum creatinine and chronic kidney disease, urinary microalbumin levels is better for patients with risks of chronic kidney diseases. With adequate and early education, or antihypertensive agents with angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), all could alleviate renal function deterioration and the severity of proteinuria. As a result, high sensitive methods is urgent and needed for early screening and diseases following up under medication with ACEi and ARB in chronic kidney disease patients. In this project, the investigators are going to include the patients with typy II diabetes mellitus combining with hypertension who are treated with antihypertensive agents. Such volunteers will be treated with Candesartan 8-16mg/ day and maintain systolic blood pressure <130 mm/Hg, diastolic blood pressure < 80 mm/ Hg as the goal. Therefore, this project would make effort on correlation with urinary microalbumin and other biomarkers changes under Candesartan treatment- one of ARB medication for 12 weeks, and further exploration of new biomarkers that may be related to renal parenchymal injuries.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Eligibility Criteria

Male or female participants from 30 years up to 75 years old.

Inclusion Criteria: 1. Type II Diabetic disease with hypertension (BP: systolic 140-160 mm/Hg, diastolic 80-100 mm/Hg) for 8 weeks. 2. HbA1c< 8.0% 3. Cre. <1.5 g/dL and eGFR: 89 - 30 mL/min/1.73 m2 Exclusion Criteria: 1. Pregnancy 2. During the observation, BP: systolic >160 mm/Hg, diastolic >100 mm/Hg).

Additional Information

Official title An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy
Principal investigator Yu Chu-Su, PhD candidate
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.