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Establishment of Aldosterone and Renin Reference Range (ARR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05232162
Recruitment Status : Recruiting
First Posted : February 9, 2022
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
University Malaysia Sarawak

Brief Summary:

Elevated aldosterone levels were also shown to contribute to the excess morbidity and mortality. Literature shows aldosterone and renin levels differ between ethnicity and gender. There is no established reference intervals for these two hormone levels in Asian community. We aim to establish reference intervals for plasma aldosterone and direct renin concentrations among Malaysians residing in Sarawak using the chemiluminescent immunoassay (CLIA).

This is a cross-sectional study which will be conducted among ambulatory patients, healthy blood donors and healthy volunteers. 300 participants who fulfil study criteria will be recruited after informed consent.

Socio-demographic data and anthropometric measurements will be recorded. Blood will be taken for plasma aldosterone, renin, serum potassium and creatinine. Urine will be collected for estimation of 24-hour sodium excretion. Aldosterone and renin reference intervals will be established partitioned for gender.


Condition or disease
Aldosteronism

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Establishment of Reference Ranges for Aldosterone and Renin in a Multi-racial Community Using the Chemiluminescent Immunoassay (CLIA)
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Aldosterone and renin reference intervals [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Aldosterone and renin reference intervals partitioned for gender [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory healthy volunteers
Criteria

Inclusion Criteria:

  1. aged 18 years old and above
  2. agreeable to participate in this study
  3. normal kidney function (eGFR>60ml/min/1.73m2)
  4. Malaysian
  5. BMI<27.5kg/m2

Exclusion Criteria:

  1. taking prescribed/OTC medications within 3 months of study
  2. taking estrogen, either in oral contraceptive pills or hormone replacement therapy
  3. having hypertension defined as blood pressure>140/90mmHg or on anti-hypertensive
  4. having hypokalemia (serum potassium <3.5mmol/L)
  5. pregnant
  6. smoker

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): NCT05232162


Contacts
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Contact: Huai Heng H Loh 0122010765 hhloh@unimas.my

Locations
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Malaysia
Universiti Malaysia Sarawak Recruiting
Kuching, Sarawak, Malaysia, 93350
Contact: Huai Heng H Loh    0122010765    hhloh@unimas.my   
Sponsors and Collaborators
University Malaysia Sarawak
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Responsible Party: University Malaysia Sarawak
ClinicalTrials.gov Identifier: NCT05232162    
Other Study ID Numbers: ARR reference range
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: January 2022
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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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases