This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: January 6, 2011
Last updated: January 7, 2011
Last verified: September 2010
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.

Diabetic Nephropathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples Without DNA
Serum and Urine

Estimated Enrollment: 100
Study Start Date: September 2010

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01273675

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

Responsible Party: Chu-Su, Yu, National Taiwan University Hospital Identifier: NCT01273675     History of Changes
Other Study ID Numbers: 201008056R
Study First Received: January 6, 2011
Last Updated: January 7, 2011

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 processed this record on September 21, 2017