Gonadal Hormone, Gonadotropin and Cardiovascular Events

Study Overview
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Brief Summary
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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.

Official Title
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Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events

Conditions
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Aging, Menopause

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| female, premenopause<br>Women with regular menstrual cycles in normal range (22-35 days) for the previous three cycles. | |
| female, perimenopause<br>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. | |
| Serum FSH level Quartile 1<br>Serum FSH level: <6.95 mIU/mL | |
| Serum FSH level Quartile 2<br>Serum FSH level: 6.95-10.87 mIU/mL | |
| Serum FSH level Quartile 3<br>Serum FSH level: 10.88-25.45 mIU/mL | |
| Serum FSH level Quartile 4<br>Serum FSH level: >25.45 mIU/mL | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Cardiovascular disease mortality | Total deaths from cardiovascular disease over a given period of time | Measured after 10 years of follow-up | 
| All-cause mortality | Total deaths from all causes over a given period of time | Measured after 10 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonadal hormones, Gonadotropins, Cardiovascular diseases, Lipids, Obesity, Atherosclerosis, Glucose metabolism disorders, Metabolic syndrome, Non-alcoholic fatty liver disease