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Gonadal Hormone, Gonadotropin and Cardiovascular Events

Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02810821
Enrollment
8000
Registered
2016-06-23
Start date
2011-07-31
Completion date
2023-06-30
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Menopause

Keywords

Gonadal hormones, Gonadotropins, Cardiovascular diseases, Lipids, Obesity, Atherosclerosis, Glucose metabolism disorders, Metabolic syndrome, Non-alcoholic fatty liver disease

Brief summary

Deficiency in gonadal hormone has been considered to play a role in ageing related increased incidence of cardiovascular events. But the mechanism has not been fully elucidated. On the other hand, the dramatic increase in gonadotropin level didn't drew much attention when talking about the increased risk of cardiovascular disease during menopausal transition. This study aim to investigate the association between gonadal hormone, gonadotropin and long-term cardiovascular events.

Interventions

None listed

Sponsors

Shandong Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female with intact uterus and at least one ovary * Aged of 18 to 75 years old;

Exclusion criteria

* Pregnancy or lactation women; * Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome or other endocrinal and metabolic disorders that known to compromise hypothalamic-pituitary-gonadal function; * Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies; * Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health; * Obviously poor compliance.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortalityMeasured after 10 years of follow-upTotal deaths from all causes over a given period of time
Rate of first cardiovascular disorder eventsMeasured after 10 years of follow-upTotal incidence rate from cardiovascular disorder over a given period of time
Cardiovascular disease mortalityMeasured after 10 years of follow-upTotal deaths from cardiovascular disease over a given period of time

Secondary

MeasureTime frameDescription
Change in serum lipid levelsMeasured at baseline, and every 2 years during the 10-year follow-up periodInclude triglycerides、cholesterol、 low density lipoprotein cholesterol、 high density lipoprotein cholesterol.
Number of participants that diagnosed with non-alcoholic fatty liver diseaseMeasured at baseline, and every 2 years during the 10-year follow-up periodA clinicopathological syndrome characterized by excessive deposition of fat in liver cells due to alcohol and other clearly damaging factors is excluded
Change in thickness of blood vessel wallMeasured at baseline, and every 2 years during the 10-year follow-up periodThe mean carotid Intima media thickness showed the early risk of atherosclerotic cardiovascular diseasean. the subclinical atherosclerosis was defined as the mean carotid Intima media thickness ≥0.78mm.
Number of participants that diagnosed with metabolic syndromeMeasured at baseline, and every 2 years during the 10-year follow-up periodMetabolic syndrome refers to the pathological state in which protein, fat, carbohydrate and other substances in human body have metabolic disorders. It is a group of complex metabolic disorders and a risk factor leading to cardiovascular and cerebrovascular diseases of diabetes.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026