The Biological Rhythm of Human Metabolite

Sponsor

Shandong Provincial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03669809

Collaborator

(none)

200

Enrollment

Location

468

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhythm Nodal Metabolism and Nutrition Disorder Metabolism Disorder, Lipid

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Association Between Serum Metabolism Markers and Biological Rhythm

Study Start Date :

May 1, 2011

Anticipated Primary Completion Date :

May 1, 2050

Anticipated Study Completion Date :

May 1, 2050

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

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]
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 urine metabolite [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]
change in sperm quality [Measured at baseline, and every 10 years during the 40-year follow-up period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.