Status:
COMPLETED
Effect of Olmesartan on Angiotensin(1-7) Levels and Vascular Functions in Diabetes and Hypertension
Lead Sponsor:
Seoul National University Bundang Hospital
Conditions:
Angiotensin/Renin/Aldosterone Hypertension
Hypertension
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
In this study, we will assess the change of serum ACE-2, angiotensin(1-7), and vascular function after using olmesartan (an ARB), compared to conventional anti-hypertensive drug, amlodipine in hyperte...
Detailed Description
Both ACE inhibitor and ARB produce inhibition of the renin-angiotensin system, so clinicians have regarded ACE inhibitor and ARB as effectively equivalent, including blood pressure lowering, improveme...
Eligibility Criteria
Inclusion
- ≥ 30 years old
- Type 2 diabetes by American Diabetes Association criteria
- HbA1c: 6.5% ≤ - \< 10.0%
- Systolic blood pressure: 140 ≤ - \< 180 mmHg or Diastolic blood pressure: 85 ≤ - \< 110 mmHg
- Statin (-) or no change in low to moderate intensity statin \[14\] dose in recent 3 months
Exclusion
- Contraindication of olmesartan or amlodipine
- History of RAS inhibitors (ACE inhibitors or ARBs) or calcium channel blockers in the previous 3 months
- Pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women
- Type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy
- Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
- Chronic kidney disease (serum creatinine \> 2.0 mg/dL)
- Hyperkalemia serum potassium \>5.0 mEq/L
- Any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05189015
Start Date
January 1 2021
End Date
June 30 2023
Last Update
August 14 2023
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707