Gonadal Hormone, Gonadotropin and Cardiovascular Events

NCT ID: NCT02810821

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 8000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2023-06-30

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.

Conditions

Aging; Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

female, premenopause

Women with regular menstrual cycles in normal range (22-35 days) for the previous three cycles.

No interventions assigned to this group

female, perimenopause

Peri-menopause was defined as the presence of menses within the past 3 months with a decrease in cycle predictability in the year preceding examination or 3-11 months of amenorrhea. To investigate the association between serum FSH and cholesterol levels independent of E2, we further selected peri-menopausal subjects with the presence of menses within the past 3 months with a decrease in cycle predictability in the year preceding examination because their E2 levels have been reported to be similar to those in pre-menopause.

No interventions assigned to this group

Serum FSH level Quartile 1

Serum FSH level: \<6.95 mIU/mL

No interventions assigned to this group

Serum FSH level Quartile 2

Serum FSH level: 6.95-10.87 mIU/mL

No interventions assigned to this group

Serum FSH level Quartile 3

Serum FSH level: 10.88-25.45 mIU/mL

No interventions assigned to this group

Serum FSH level Quartile 4

Serum FSH level: \>25.45 mIU/mL

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jia-jun Zhao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiajun Zhao

Role: STUDY_CHAIR

Shandong Provincial Hospital

Locations

Shandong Provincial Hospital

Jinan, Shandong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 30559440 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/30559440/

NCBI link

Other Identifiers

20140722

Identifier Type: -

Identifier Source: org_study_id