Sex Hormones and Blood PCSK9 Levels

NCT00848276 | Completed

• 1 other identifier: 2008138-01H
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study measures a recently discovered protein named PCSK9 (Proprotein convertase subtilisin kexin 9) in blood to see if it is influenced by male and female sex hormones. PCSK9 has recently been shown to control cholesterol and triglyceride levels by diminishing the ability of liver cells to remove cholesterol from blood leading to high blood cholesterol levels. It was found in previous studies that there was a relationship between blood levels of PCSK9 and cholesterol in men but not in women. This gender difference is a new finding and it raises the question of whether male and female hormones might influence PCSK9's role as a blood cholesterol regulator. The study requires a pre-treatment fasting blood sample and another sample 3 months after starting hormone therapy.

Conditions

Hypercholesterolemia

Keywords

PCSK9; Lipoprotein metabolism; testosterone; estradiol

Study Arms (2)

1

Hypogonadal Men before and after starting testosterone replacement therapy

2

Post-menopausal women before and after starting Estrogen Replacement Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clincs

You may qualify if:

• Males:
• years of age and older for hypogonadal males/males with prostate cancer
• Prior clinical decision to start on testosterone therapy
• Females:
• years of age and older for post-menopausal women
• Prior clinical decision to start on estrogen therapy

You may not qualify if:

• Cognitive impairment, active or chronic hepatic or renal disease, diagnosed diabetes mellitus,alcohol consumption greater than 4 drinks/day
• receiving or needing progestogen therapy for women

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Ottawa Hospital Riverside Campus

Ottawa, Ontario, K1H 7W9, Canada

Location

Related Publications (1)

• Ooi TC, Raymond A, Cousins M, Favreau C, Taljaard M, Gavin C, Jolly EE, Malone S, Eapen L, Chretien M, Mbikay M, Mayne J. Relationship between testosterone, estradiol and circulating PCSK9: Cross-sectional and interventional studies in humans. Clin Chim Acta. 2015 Jun 15;446:97-104. doi: 10.1016/j.cca.2015.03.036. Epub 2015 Apr 7.

  PMID: 25858546 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Teik Chye Ooi, MBBS

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: July 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

CA (1)