The Biological Rhythm of Human Metabolite

Metabolism and Nutrition Disorder Clinical Trial

Official title:

Association Between Serum Metabolism Markers and Biological Rhythm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03669809
• Other study ID #: 20180326
• Status: Recruiting
• Start date: May 1, 2011
• Est. completion date: May 1, 2050

Study information

• Verified date: November 2021
• Source: Shandong Provincial Hospital
• Contact: Ling Gao
• Phone: +86 53168776910
• Email: gaoling1[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2050
• Est. primary completion date: May 1, 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Lipid Metabolism Disorders
• Metabolic Diseases
• Metabolism and Nutrition Disorder
• Metabolism Disorder, Lipid
• Nutrition Disorders
• Rhythm Nodal

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	change in urine metabolite		Measured at baseline, and every 10 years during the 40-year follow-up period
Secondary	change in intestinal flora		Measured at baseline, and every 10 years during the 40-year follow-up period
Secondary	change in sperm quality		Measured at baseline, and every 10 years during the 40-year follow-up period