Gonadal Hormone, Gonadotropin and Cardiovascular Events

NCT02810821 | Unknown DMC

• 1 other identifier: 20140722
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

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

Keywords

Gonadal hormones; Gonadotropins; Cardiovascular diseases; Lipids; Obesity; Atherosclerosis; Glucose metabolism disorders; Metabolic syndrome; Non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (6)

female, premenopause

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

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.

Serum FSH level Quartile 1

Serum FSH level: \<6.95 mIU/mL

Serum FSH level Quartile 2

Serum FSH level: 6.95-10.87 mIU/mL

Serum FSH level Quartile 3

Serum FSH level: 10.88-25.45 mIU/mL

Serum FSH level Quartile 4

Serum FSH level: \>25.45 mIU/mL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged of 18 to 75 years old. Part of the subjects (aged 40 years or more) were selected from REACTION study that was conducted from April,1, 2011 through May 30, 2012, aiming to investigate the epidemiology of metabolic diseases across China. The younger participants were recruited since July 1, 2014.

You may qualify if:

• Male or female with intact uterus and at least one ovary
• Aged of 18 to 75 years old;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Related 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.

  PMID: 30559440 BACKGROUND

Related Links

• NCBI link

Biospecimen

Retention: SAMPLES WITH DNA

Serum，Plasma and Whole blood

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Atherosclerosis; Glucose Metabolism Disorders; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Jiajun Zhao

  Shandong Provincial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2011
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)