Gonadal Hormone, Gonadotropin and Cardiovascular Events

Aging Clinical Trial

Official title:

Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02810821
• Other study ID #: 20140722
• Status: Active, not recruiting
• Start date: July 2011
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8000
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Menopause

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of first cardiovascular disorder events	Total incidence rate from cardiovascular disorder over a given period of time	Measured after 10 years of follow-up
Primary	Cardiovascular disease mortality	Total deaths from cardiovascular disease over a given period of time	Measured after 10 years of follow-up
Primary	All-cause mortality	Total deaths from all causes over a given period of time	Measured after 10 years of follow-up
Secondary	Change in serum lipid levels	Include triglycerides?cholesterol? low density lipoprotein cholesterol? high density lipoprotein cholesterol.	Measured at baseline, and every 2 years during the 10-year follow-up period
Secondary	Change in thickness of blood vessel wall	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.	Measured at baseline, and every 2 years during the 10-year follow-up period
Secondary	Number of participants that diagnosed with metabolic syndrome	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.	Measured at baseline, and every 2 years during the 10-year follow-up period
Secondary	Number of participants that diagnosed with non-alcoholic fatty liver disease	A clinicopathological syndrome characterized by excessive deposition of fat in liver cells due to alcohol and other clearly damaging factors is excluded	Measured at baseline, and every 2 years during the 10-year follow-up period

External Links

•   NCBI link