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
  Purpose

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
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
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01273675

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

No publications provided

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

Keywords provided by National Taiwan University Hospital:
Hypertension
Primary disease

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

ClinicalTrials.gov processed this record on July 29, 2014