Gonadal Hormone, Gonadotropin and Cardiovascular Events

Sponsor

Shandong Provincial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02810821

Collaborator

(none)

8,000

Enrollment

Location

119

Duration (Months)

67.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Menopause

Study Design

Study Type:

Observational

Anticipated Enrollment :

8000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
male
female, premenopause Women with regular menstrual cycles in normal range (22-35 days) for the previous three cycles.
female, perimenopause Women with variability in menstrual cycle length, defined as a persistent difference of 7 days or more in the length of consecutive cycles, or amenorrhea of at least 60 days but no longer than 12 months.
female, postmenopause Women with amenorrhea of at least 12 consecutive months.

Outcome Measures

Primary Outcome Measures

Rate of first cardiovascular disorder events [Measured after 10 years of follow-up]
Cardiovascular disease mortality [Measured after 10 years of follow-up]
All-cause mortality [Measured after 10 years of follow-up]

Secondary Outcome Measures

Change in serum lipid levels [Measured at baseline, and every 2 years during the 10-year follow-up period]
Change in thickness of blood vessel wall [Measured at baseline, and every 2 years during the 10-year follow-up period]
Number of participants that diagnosed with metabolic syndrome [Measured at baseline, and every 2 years during the 10-year follow-up period]
Number of participants that diagnosed with non-alcoholic fatty liver disease [Measured at baseline, and every 2 years during the 10-year follow-up period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.