An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

NCT01273675 | Unknown DMC

• 1 other identifier: 201008056R
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Nephropathy

Keywords

Hypertension; Primary disease

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Type II Diabetic disease with hypertension (BP: systolic 140-160 mm/Hg, diastolic 80-100 mm/Hg) for 8 weeks.
• HbA1c\< 8.0%
• Cre. \<1.5 g/dL and eGFR: 89 - 30 mL/min/1.73 m2

You may not qualify if:

• Pregnancy
• During the observation, BP: systolic \>160 mm/Hg, diastolic \>100 mm/Hg).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Urine

MeSH Terms

Conditions

Diabetic Nephropathies; Hypertension

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yu Chu-Su, PhD candidate

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 10, 2011
• Study Start: September 1, 2010
• Last Updated: January 10, 2011

Record last verified: 2010-09