The Biological Rhythm of Human Metabolite

Recruiting

• Conditions: Metabolism and Nutrition Disorder; Metabolism Disorder, Lipid; Rhythm Nodal

• Registration Number: NCT03669809
• Lead Sponsor: Shandong Provincial Hospital

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-01
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Status Verified: 2021-11
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11
• Primary Completion: 2050-05-01
• Study Completion: 2050-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
circadian rhythms of serum lipid levels （the change of serum lipid levels within 24 hours）	Measured at baseline, and every 10 years during the 40-year follow-up period

Secondary Outcome Measures

Name	Time	Method
circadian rhythms of gonadal hormone and gonadotropin（the change of gonadal hormone and gonadotropin within 24 hours）	Measured at baseline, and every 10 years during the 40-year follow-up period
change in urine metabolite	Measured at baseline, and every 10 years during the 40-year follow-up period
change in sperm quality	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 at baseline, and every 10 years during the 40-year follow-up period
change in intestinal flora	Measured at baseline, and every 10 years during the 40-year follow-up period

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China