AgingNCT02810821
Gonadal Hormone, Gonadotropin and Cardiovascular Events
An observational study of Aging and Menopause, run by Shandong Provincial Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male or female with intact uterus and at least one ovary
- Aged of 18 to 75 years old;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events
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.
- Keywords
- Gonadal hormones, Gonadotropins, Cardiovascular diseases, Lipids, Obesity, Atherosclerosis, Glucose metabolism disorders, Metabolic syndrome, Non-alcoholic fatty liver disease
- Medical subject headings
- Cardiovascular Diseases, Obesity, Atherosclerosis, Glucose Metabolism Disorders, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of first cardiovascular disorder events
Total incidence rate from cardiovascular disorder over a given period of time
Measured: Measured after 10 years of follow-up
Cardiovascular disease mortality
Total deaths from cardiovascular disease over a given period of time
Measured: Measured after 10 years of follow-up
All-cause mortality
Total deaths from all causes over a given period of time
Measured: Measured after 10 years of follow-up
Secondary outcomes (4)
Change in serum lipid levels
Include triglycerides、cholesterol、 low density lipoprotein cholesterol、 high density lipoprotein cholesterol.
Measured: 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: 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: 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: Measured at baseline, and every 2 years during the 10-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2011
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jia-jun Zhao, Shandong Provincial Hospital
- Investigators
- Jiajun Zhao, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810821
- Sponsor's protocol ID
- 20140722
- Status last verified
- Apr 2023
- First submitted
- 11 Jun 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30559440
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events
- ClinicalTrials.gov ID
- NCT02810821
- Acronym / sponsor ID
- 20140722
- Keywords
- Gonadal hormones, Gonadotropins, Cardiovascular diseases, Lipids, Obesity, Atherosclerosis, Glucose metabolism disorders, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- Jul 2011
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or female with intact uterus and at least one ovary
- Aged of 18 to 75 years old;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of first cardiovascular disorder events
Time frame: Measured after 10 years of follow-up
Total incidence rate from cardiovascular disorder over a given period of time
Cardiovascular disease mortality
Time frame: Measured after 10 years of follow-up
Total deaths from cardiovascular disease over a given period of time
All-cause mortality
Time frame: Measured after 10 years of follow-up
Total deaths from all causes over a given period of time
4 secondary outcomes
Change in serum lipid levels
Time frame: Measured at baseline, and every 2 years during the 10-year follow-up period
Change in thickness of blood vessel wall
Time frame: Measured at baseline, and every 2 years during the 10-year follow-up period
Number of participants that diagnosed with metabolic syndrome
Time frame: 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
Time frame: Measured at baseline, and every 2 years during the 10-year follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 30559440Guo 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.
- NCBI linkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiajun Zhao study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Menopause, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of first cardiovascular disorder events (time frame: Measured after 10 years of follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.