The Biological Rhythm of Human Metabolite

May 10, 2022 updated by: Jia-jun Zhao, Shandong Provincial Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults aged of 18 to 30 years old.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at baseline, and every 10 years during the 40-year follow-up period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
Measured at baseline, and every 10 years during the 40-year follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

May 1, 2050

Study Completion (Anticipated)

May 1, 2050

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180326

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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