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Cross-sectional Study on the TCM Syndrome of Damp-Heat in Glycolipid Metabolic Diseases Based on Multi-omics Technology

Cross-sectional Study on the TCM Syndrome of Damp-Heat in Glycolipid Metabolic Diseases Based on Multi-omics Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2024000300
Enrollment
Unknown
Registered
2024-08-26
Start date
2022-08-23
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Glycolipid Metabolic Diseases

Interventions

Non diabetic group with damp heat syndrome:N/A
Diabetes mellitus patients with syndrome of damp-heat:N/A
Diabetes non damp heat syndrome group:N/A

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Inclusion Criteria for Diabetic Patients with Damp-Heat Syndrome 1) Age range from 18 to 75 years old, regardless of gender; 2) Meet the diagnostic criteria for Type 2 Diabetes Mellitus (T2DM) and the diagnostic criteria for Damp-Heat Syndrome in Traditional Chinese Medicine (TCM); 3) Provide signed informed consent. (2) Inclusion Criteria for Diabetic Patients without Damp-Heat Syndrome 1) Age range from 18 to 75 years old, regardless of gender; 2) Meet the diagnostic criteria for T2DM and the diagnostic criteria for non-Damp-Heat Syndrome in TCM; 3) Provide signed informed consent. (3) Inclusion Criteria for Non-Diabetic Individuals with Damp-Heat Syndrome 1) Age range from 18 to 75 years old, regardless of gender; 2) Meet the diagnostic criteria for Damp-Heat Syndrome in TCM; 3) Meet at least one of the diagnostic criteria for obesity or hyperlipidemia; 4) Subjects without risk factors for Type 2 Diabetes Mellitus, with fasting blood glucose levels < 6.1 mmol/L and glycated hemoglobin (HbA1c) < 5.7% (indicating normal glucose metabolism); 5) Provide signed informed consent. (4) Inclusion Criteria for Normal Control Group 1) Age range from 18 to 75 years old, regardless of gender; 2) Meet the diagnostic criteria for the normal control group; 3) Provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with primary diseases of heart, liver, kidney, endocrine system or acute and chronic gastrointestinal diseases; 2. Patients with mental illness; 3. Pregnant or lactating patients; 4. Taking drugs that may affect intestinal flora in recent 2 months, such as antibiotics, berberine, defecation drugs, bifidobacteria, etc; 5. Those who had received external enema therapy within 1 month before sampling.

Design outcomes

Primary

MeasureTime frame
Tongue microcirculation image;fecal sample amplicon;oral metagenome;Stool sample flora detection;oral sample amplicon;Traditional Chinese Medicine information;metabolomics of fecal samples;Metabolomics of blood samples;Detection of water molecules in urine samples;metabolomics of oral samples;Metabolomics of urine samples;glycosylated hemoglobin;Single cell sequencing of blood samples;blood glucose;Tongue color photo examination;Urine sample proteomics;proteomics of oral samples;Western blot verification of blood samples;Fundus color photograph examination;Detection of inflammatory factors and cytokines in blood samples;fecal sample metagenome;Blood sample proteomics;Detection of water molecules in blood samples;proteomics of fecal samples;Blood biochemistry;

Secondary

MeasureTime frame
routine blood test;Waist-to-Hip Ratio (WHR);Urinary creatinine;Past medical history;Stool routine;Age;Gender;urinalysis;electrocardiogram;Body Mass Index (BMI);Urinary microalbumin;

Countries

China

Contacts

Public ContactLiu hongfang

Dongzhimen Hospital, Beijing University of Chinese Medicine

lhfdoctor@126.com+86 188 0117 5242

Outcome results

None listed

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