The Biological Rhythm of Human Metabolite

NCT03669809 | Recruiting DMC

• 1 other identifier: 20180326
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhythm Nodal; Metabolism and Nutrition Disorder; Metabolism Disorder, Lipid

Keywords

biological rhythm; metabolism; hormone; lipid; bile acids; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adults aged of 18 to 30 years old.

You may qualify if:

• Male or female；
• Aged of 18 to 30 years old;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum，plasma, whole blood, urine, feces and seminal fluid

MeSH Terms

Conditions

Nutrition Disorders; Lipid Metabolism Disorders; Obesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiajun Zhao

  Shandong Provincial Hospital

  STUDY CHAIR

Central Study Contacts

Ling Gao

CONTACT

+86 53168776910; gaoling1@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: September 13, 2018
• Study Start: May 1, 2011
• Primary Completion (Estimated): May 1, 2050
• Study Completion (Estimated): May 1, 2050
• Last Updated: May 11, 2022

Record last verified: 2021-11

Locations

CN (1)