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The Biological Rhythm of Human Metabolite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669809
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jia-jun Zhao, 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.

Condition or disease
Rhythm Nodal Metabolism and Nutrition Disorder Metabolism Disorder, Lipid

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 1, 2050
Estimated Study Completion Date : May 1, 2050

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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. change in urine metabolite [ Time Frame: Measured at baseline, and every 10 years during the 40-year follow-up period ]
  4. change in intestinal flora [ Time Frame: Measured at baseline, and every 10 years during the 40-year follow-up period ]
  5. change in sperm quality [ Time Frame: Measured at baseline, and every 10 years during the 40-year follow-up period ]

Biospecimen Retention:   Samples With DNA
serum,plasma, whole blood, urine, feces and seminal fluid


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults aged of 18 to 30 years old.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669809


Locations
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China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Study Chair: Jiajun Zhao Shandong Provincial Hospital
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Responsible Party: Jia-jun Zhao, Professor, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT03669809    
Other Study ID Numbers: 20180326
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jia-jun Zhao, Shandong Provincial Hospital:
biological rhythm
metabolism
hormone
lipid
bile acids
obesity
Additional relevant MeSH terms:
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Metabolic Diseases
Nutrition Disorders
Lipid Metabolism Disorders
Disease
Pathologic Processes