Clinical trial NCT02810821: Gonadal Hormone, Gonadotropin and Cardiovascular Events
Official title: Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging
Menopause
Keywords: Gonadal hormones
Gonadotropins
Cardiovascular diseases
Lipids
Obesity
Atherosclerosis
Glucose metabolism disorders
Metabolic syndrome
Non-alcoholic fatty liver disease
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2016-06-23
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged of 18 to 75 years old. Part of the subjects (aged 40 years or more) were selected from REACTION study that was conducted from April,1, 2011 through May 30, 2012, aiming to investigate the epidemiology of metabolic diseases across China. The younger participants were recruited since July 1, 2014.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of first cardiovascular disorder events
timeFrame: Measured after 10 years of follow-up
measure: Cardiovascular disease mortality
timeFrame: Measured after 10 years of follow-up
measure: All-cause mortality
timeFrame: Measured after 10 years of follow-up
Secondary outcomes:
measure: Change in serum lipid levels
timeFrame: Measured at baseline, and every 2 years during the 10-year follow-up period
measure: Change in thickness of blood vessel wall
timeFrame: Measured at baseline, and every 2 years during the 10-year follow-up period
measure: Number of participants that diagnosed with metabolic syndrome
timeFrame: Measured at baseline, and every 2 years during the 10-year follow-up period
measure: Number of participants that diagnosed with non-alcoholic fatty liver disease
timeFrame: Measured at baseline, and every 2 years during the 10-year follow-up period
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Jiajun Zhao
role: STUDY_CHAIR
References:
citation: Guo Y, Zhao M, Bo T, Ma S, Yuan Z, Chen W, He Z, Hou X, Liu J, Zhang Z, Zhu Q, Wang Q, Lin X, Yang Z, Cui M, Liu L, Li Y, Yu C, Qi X, Wang Q, Zhang H, Guan Q, Zhao L, Xuan S, Yan H, Lin Y, Wang L, Li Q, Song Y, Gao L, Zhao J. Blocking FSH inhibits hepatic cholesterol biosynthesis and reduces serum cholesterol. Cell Res. 2019 Feb;29(2):151-166. doi: 10.1038/s41422-018-0123-6. Epub 2018 Dec 17.