Rhythm NodalNCT03669809
The Biological Rhythm of Human Metabolite
An observational study of Rhythm Nodal and Metabolism and Nutrition Disorder, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
The circadian regulation in mammals have been known for a long time. A special group of clock genes, organized in feedback loops, are responsible for the circadian regulation in both the SCN and peripheral organs. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhythm Nodal, Metabolism and Nutrition Disorder, Metabolism Disorder, Lipid
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2011to 1 May 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults aged of 18 to 30 years old.
Who may be able to join
- Male or female；
- Aged of 18 to 30 years old;
Who cannot join
- Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome， thyroid disorders, hypertension, malignant tumor, cardiac insufficiency，hepatic or renal insufficiency, gastrointestinal disorders and acute infection;
- 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;
- Pregnancy or lactation women;
- Obviously poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Shanshan Shao, +8653168776094, shaoshanshan11@126.com
About this study
Official title: Association Between Serum Metabolism Markers and Biological Rhythm
The circadian regulation in mammals have been known for a long time. A special group of clock genes, organized in feedback loops, are responsible for the circadian regulation in both the SCN and peripheral organs. The central clock is mainly entrained by the light-dark cycle, while the peripheral ones in organs such as liver and intestine, are more influenced by the feeding-fasting cycles. The coordination of central and peripheral clocks is thought to be essential in the maintenance of physiological homeostasis.This study aim to investigate the association between biological rhythm and metabolism.
- Keywords
- biological rhythm, metabolism, hormone, lipid, bile acids, obesity
- Medical subject headings
- Nutrition Disorders, Lipid Metabolism Disorders, Obesity
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 |
|---|---|---|
| male, non-obese | male with BMI<28 | |
| male, obese | male with BMI≥28 | |
| female, non-obese | female with BMI<28 | |
| female, obese | female with BMI≥28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
circadian rhythms of serum lipid levels （the change of serum lipid levels within 24 hours）
Measured: Measured at baseline, and every 10 years during the 40-year follow-up period
Secondary outcomes (5)
circadian rhythms of gonadal hormone and gonadotropin（the change of gonadal hormone and gonadotropin within 24 hours）
Measured: Measured at baseline, and every 10 years during the 40-year follow-up period
circadian rhythms of serum total bile acids（the change of serum total bile acids within 24 hours）
Measured: Measured at baseline, and every 10 years during the 40-year follow-up period
change in urine metabolite
Measured: Measured at baseline, and every 10 years during the 40-year follow-up period
change in intestinal flora
Measured: Measured at baseline, and every 10 years during the 40-year follow-up period
change in sperm quality
Measured: Measured at baseline, and every 10 years during the 40-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 posted13 Sep 2018
- Study start1 May 2011
- Primary completion1 May 2050 (estimated)
- Study completion1 May 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhythm NodalStudies 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
- Other
- Enrolment
- 200 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
- NCT03669809
- Sponsor's protocol ID
- 20180326
- Status last verified
- Nov 2021
- First submitted
- 3 Apr 2018
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum Metabolism Markers and Biological Rhythm
- ClinicalTrials.gov ID
- NCT03669809
- Acronym / sponsor ID
- 20180326
- Keywords
- biological rhythm, metabolism, hormone, lipid, bile acids, obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 May 2011
- Primary completion
- 1 May 2050 (estimated)
- Study completion
- 1 May 2050 (estimated)
- First posted
- 13 Sep 2018 (actual)
- 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.
The circadian regulation in mammals have been known for a long time. A special group of clock genes, organized in feedback loops, are responsible for the circadian regulation in both the SCN and peripheral organs. The central clock is mainly entrained by the light-dark cycle, while the peripheral ones in organs such as liver and intestine, are more influenced by the feeding-fasting cycles. The coordination of central and peripheral clocks is thought to be essential in the maintenance of physiological homeostasis.This study aim to investigate the association between biological rhythm and metabolism.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| male, non-obese | – | –male with BMI<28 |
| male, obese | – | –male with BMI≥28 |
| female, non-obese | – | –female with BMI<28 |
| female, obese | – | –female with BMI≥28 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults aged of 18 to 30 years old.
Key inclusion criteria (2 listed)
- Male or female；
- Aged of 18 to 30 years old;
Key exclusion criteria (5 listed)
- Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome， thyroid disorders, hypertension, malignant tumor, cardiac insufficiency，hepatic or renal insufficiency, gastrointestinal disorders and acute infection;
- 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;
- Pregnancy or lactation women;
- 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
circadian rhythms of serum lipid levels （the change of serum lipid levels within 24 hours）
Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period
5 secondary outcomes
circadian rhythms of gonadal hormone and gonadotropin（the change of gonadal hormone and gonadotropin within 24 hours）
Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period
circadian rhythms of serum total bile acids（the change of serum total bile acids within 24 hours）
Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period
change in urine metabolite
Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period
change in intestinal flora
Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period
change in sperm quality
Time frame: Measured at baseline, and every 10 years during the 40-year follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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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.
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 Rhythm Nodal and Metabolism and Nutrition Disorder, 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: looking for participants now, as of the sponsor's last update on 11 May 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Gao (+86 53168776910, gaoling1@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circadian rhythms of serum lipid levels （the change of serum lipid levels within 24 hours） (time frame: Measured at baseline, and every 10 years during the 40-year follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2022.