An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01273675
First received: January 6, 2011
Last updated: January 7, 2011
Last verified: September 2010

January 6, 2011
January 7, 2011
September 2010
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Complete list of historical versions of study NCT01273675 on ClinicalTrials.gov Archive Site
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An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy
An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Serum and Urine

Non-Probability Sample

Type II Diabetic diasese with hypertension ( systolic 140-160 mm/Hg, dystolic 80-100 mm/Hg) for 8 weeks.

Diabetic Nephropathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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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).
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01273675
201008056R
Yes
Chu-Su, Yu, National Taiwan University Hospital
National Taiwan University Hospital
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Principal Investigator: Yu Chu-Su, PhD candidate National Taiwan University Hospital
National Taiwan University Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP