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Effect of Olmesartan on Angiotensin(1-7) Levels and Vascular Functions in Diabetes and Hypertension (Ang(1-7))

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ClinicalTrials.gov Identifier: NCT05189015
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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 hypertensive patients with T2DM.

Condition or disease Intervention/treatment Phase
Angiotensin/Renin/Aldosterone Hypertension Hypertension Diabetes Mellitus, Type 2 Drug: Olmesartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Olmesartan or Amlodipine on Serum Angiotensin(1-7) Levels and Vascular Functions in Patients With Type 2 Diabetes and Hypertension
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Olmesartan
- Olmesartan group: Olmesartan, 20 (40) mg once a day, oral administration
Drug: Olmesartan
- Olmesartan group: Olmesartan, 20 (40) mg once a day, oral administration
Other Name: Olmesartan medoxomil

Active Comparator: Amlodipine
- Comparator group: Amlodipine, 5 (10) mg once a day, oral administration
Drug: Olmesartan
- Olmesartan group: Olmesartan, 20 (40) mg once a day, oral administration
Other Name: Olmesartan medoxomil




Primary Outcome Measures :
  1. angiotensin(1-7) [ Time Frame: 24 weeks ]
    Changes of serum angiotensin(1-7) at week 24 from baseline


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 24 weeks ]
    Change in blood pressure from baseline to week 24

  2. ACE-2 [ Time Frame: 24 weeks ]
    Changes of serum ACE-2 at week 24 from baseline

  3. Renin [ Time Frame: 24 weeks ]
    Changes of serum renin at week 24 from baseline

  4. Aldosterone [ Time Frame: 24 weeks ]
    Changes of serum aldosterone at week 24 from baseline

  5. hsCRP [ Time Frame: 24 weeks ]
    Changes of serum hsCRP at week 24 from baseline

  6. HbA1c [ Time Frame: 24 weeks ]
    Change in HbA1c from baseline to week 24

  7. glucose [ Time Frame: 24 weeks ]
    Change in fasting glucose from baseline to week 24

  8. Insulin [ Time Frame: 24 weeks ]
    Change in fasting insulin from baseline to week 24

  9. FMD [ Time Frame: 24 weeks ]
    Change in flow mediated vasodilatation (FMD) from baseline to week 24

  10. Microcirculation [ Time Frame: 24 weeks ]
    Change in microcirculation from baseline to week 24

  11. TG [ Time Frame: 24 weeks ]
    Change in triglycerides from baseline to week 24

  12. HDL [ Time Frame: 24 weeks ]
    Change in HDL cholesterol from baseline to week 24

  13. LDL [ Time Frame: 24 weeks ]
    Change in LDL cholesterol from baseline to week 24



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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 Criteria:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT05189015


Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Soo Lim, MD, PHD    82-31-787-7035    limsoo@snu.ac.kr   
Principal Investigator: Soo Lim, MD, PHD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT05189015    
Other Study ID Numbers: B-1608-359-005
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action