The Biological Rhythm of Human Metabolite
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rhythm Nodal, Metabolism and Nutrition Disorder, Metabolism Disorder, Lipid. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association Between Serum Metabolism Markers and Biological Rhythm
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- Male or female；
- Aged of 18 to 30 years old;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shandong Provincial Hospital — Jinan
Identifiers
NCT: NCT03669809 · 20180326