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Study on the Clinical Mechanisms and Biomarkers of Sleep Deprivation-Induced Liver Injury Mediated by Gut Microbiota Dysbiosis

Study on the Clinical Mechanisms and Biomarkers of Sleep Deprivation-Induced Liver Injury Mediated by Gut Microbiota Dysbiosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105310
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep deprivation

Interventions

Control Group:None
Acute sleep deprivation group:None

Sponsors

Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Control Group: Age range: Healthy adults aged 20–40 years, with stable metabolic and immune function. Lifestyle: Maintained regular sleep patterns over the past three months (7–9 hours of sleep per night, bedtime <=11:00 PM). No history of chronic sleep deprivation (<=1 night of late sleeping per week), heavy alcohol consumption (alcohol intake <20 g/day for males, <10 g/day for females), or smoking. Diet control: Followed a standardized diet from two weeks before the study until its completion (to avoid interference with gut microbiota by high-fat or high-sugar diets). No gastrointestinal disorders: No history of inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, or constipation; no use of antibiotics, probiotics, or laxatives in the past month. Adequate sleep quality: Pittsburgh Sleep Quality Index (PSQI) score <=5; individuals with insomnia, sleep apnea, or other sleep disorders at baseline were excluded. 2.Acute sleep deprivation group: In addition to meeting all the above criteria, subjects have experienced recent acute sleep deprivation—defined as less than 5 hours of sleep per day over the past three days or continuous wakefulness for 24 hours.

Exclusion criteria

Exclusion criteria: 1. Medical History and Medication Use Liver diseases: Fatty liver, viral hepatitis (HBV/HCV positive), cirrhosis, or hepatic fibrosis. Metabolic diseases: Diabetes, obesity (BMI >=28), thyroid dysfunction, or autoimmune diseases. Mental health conditions: Depression, anxiety, or a history of using psychotropic medications (e.g., SSRIs). Recent infections: Acute infections within one month prior to the study (e.g., upper respiratory tract infections, gastroenteritis). 2. Exclusion of Confounding Factors Special diets: Vegetarians, individuals on ketogenic diets, or those recently participating in other clinical trials. Medication interference: Use of immunosuppressants, corticosteroids, or hepatotoxic drugs (e.g., acetaminophen) within three months prior to the study. Pregnancy/lactation: Not pregnant or lactating. 3. Additional Exclusion Criteria Non-compliance: Unable to complete the sleep deprivation intervention. Risk of sample contamination: Planning long-distance travel during the study period (interference due to jet lag) or requiring emergency medication. Genetic background interference: Family history of liver disease or hereditary abnormalities in gut microbiota (e.g., familial adenomatous polyposis).

Design outcomes

Primary

MeasureTime frame
ALT/ GPT;AST / GOT;TB;ALB;CRP;IL-6;TNF-a;TC;TG;FBG;16S rDNA gene ;PLT;

Secondary

MeasureTime frame
Hb;WBC;

Countries

China

Contacts

Public ContactHe Songqi

Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

hesongqijz@126.com+86 136 9749 9297

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026