Gonadal Hormone, Gonadotropin and Cardiovascular Events

Active, not recruiting

• Conditions: Aging; Menopause

• Registration Number: NCT02810821
• Lead Sponsor: Shandong Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2016-06-11
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular disease mortality	Measured after 10 years of follow-up	Total deaths from cardiovascular disease over a given period of time
Rate of first cardiovascular disorder events	Measured after 10 years of follow-up	Total incidence rate from cardiovascular disorder over a given period of time
All-cause mortality	Measured after 10 years of follow-up	Total deaths from all causes over a given period of time

Secondary Outcome Measures

Name	Time	Method
Change in serum lipid levels	Measured at baseline, and every 2 years during the 10-year follow-up period	Include triglycerides、cholesterol、 low density lipoprotein cholesterol、 high density lipoprotein cholesterol.
Number of participants that diagnosed with metabolic syndrome	Measured at baseline, and every 2 years during the 10-year follow-up period	Metabolic 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.
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	A 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 wall	Measured at baseline, and every 2 years during the 10-year follow-up period	The 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.

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China