An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01273675
Recruitment Status : Unknown
Verified September 2010 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Information provided by:
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease
Diabetic Nephropathy

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy
Study Start Date : September 2010

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA
Serum and Urine

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type II Diabetic diasese with hypertension ( systolic 140-160 mm/Hg, dystolic 80-100 mm/Hg) for 8 weeks.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01273675

Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Yu Chu-Su, PhD candidate National Taiwan University Hospital

Responsible Party: Chu-Su, Yu, National Taiwan University Hospital Identifier: NCT01273675     History of Changes
Other Study ID Numbers: 201008056R
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: September 2010

Keywords provided by National Taiwan University Hospital:
Primary disease

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action