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Gonadal Hormone, Gonadotropin and Cardiovascular Events

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810821
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jia-jun Zhao, 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.

Condition or disease
Aging Menopause

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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events
Study Start Date : July 2011
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort
male
female, premenopause
Women with regular menstrual cycles in normal range (22-35 days) for the previous three cycles.
female, perimenopause
Women with variability in menstrual cycle length, defined as a persistent difference of 7 days or more in the length of consecutive cycles, or amenorrhea of at least 60 days but no longer than 12 months.
female, postmenopause
Women with amenorrhea of at least 12 consecutive months.



Primary Outcome Measures :
  1. Rate of first cardiovascular disorder events [ Time Frame: Measured after 10 years of follow-up ]
  2. Cardiovascular disease mortality [ Time Frame: Measured after 10 years of follow-up ]
  3. All-cause mortality [ Time Frame: Measured after 10 years of follow-up ]

Secondary Outcome Measures :
  1. Change in serum lipid levels [ Time Frame: Measured at baseline, and every 2 years during the 10-year follow-up period ]
  2. Change in thickness of blood vessel wall [ Time Frame: Measured at baseline, and every 2 years during the 10-year follow-up period ]
  3. Number of participants that diagnosed with metabolic syndrome [ Time Frame: Measured at baseline, and every 2 years during the 10-year follow-up period ]
  4. Number of participants that diagnosed with non-alcoholic fatty liver disease [ Time Frame: Measured at baseline, and every 2 years during the 10-year follow-up period ]

Biospecimen Retention:   Samples With DNA
Serum,Plasma and Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810821


Locations
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China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Study Chair: Jiajun Zhao Shandong Provincial Hospital
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Responsible Party: Jia-jun Zhao, Professor, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT02810821    
Other Study ID Numbers: 20140722
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Keywords provided by Jia-jun Zhao, Shandong Provincial Hospital:
Gonadal hormones
Gonadotropins
Cardiovascular diseases
Lipids
Obesity
Atherosclerosis
Glucose metabolism disorders
Metabolic syndrome
Non-alcoholic fatty liver disease