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Exploring the effects of biased constitution of traditional Chinese medicine on the occurrence and development of diabetes and its biological mechanism based on multi-omics dataA prospective cohort study

Exploring the effects of biased constitution of traditional Chinese medicine on the occurrence and development of diabetes and its biological mechanism based on multi-omics dataA prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2024000774
Enrollment
Unknown
Registered
2024-12-08
Start date
2024-12-10
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Diabetes

Interventions

Diabetic population with biased constitution (Qi-deficiency type Yin-deficiency type Yang-deficiency type wet-heat type phlegm-wetness type Qi-depression type blood-stasis type special-diathesis type)
Prediabetic population with biased constitution (Qi-deficiency type Yin-deficiency type Yang-deficiency type wet-heat type phlegm-wetness type Qi-depression type blood-stasis type special-diathesis ty
Healthy people with biased constitution (Qi-deficiency type Yin-deficiency type Yang-deficiency type wet-heat type phlegm-wetness type Qi-depression type blood-stasis type special-diathesis type):Non
Diabetic population with a gentleness constitution:Non
Prediabetic population with a gentleness constitution:Non
Healthy people with a gentleness constitution:Non

Sponsors

The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male and female participants aged between 20 and 75 years old (including boundaries); 2. Meet the diagnostic criteria for healthy individuals; 3. Meet the diagnostic criteria of prediabetes; 4. Meet the diagnostic criteria of type 2 diabetes.

Exclusion criteria

Exclusion criteria: 1. Patients with other types of diabetes mellitus rather than T2DM. 2. Those with severe combined diabetic complications such as diabetic ketoacidosis hyperosmolar hyperglycemic syndrome or lactic acidosis. 3. Patients with clinically significant hepatobiliary disease including but not limited to chronic active hepatitis and/or severe hepatic insufficiency cirrhosis glutamic aminotransferase (ALT) or glutamic oxalacetic aminotransferase (AST) > 3 times the upper limit of normal (150 U/L) or serum total bilirubin (TB) > 34.2 µmol/L (>2 mg/dL). 4. Patients with the following history of renal disease or features associated with renal disease: history of unstable or rapidly progressive renal disease patients with moderate/severe renal impairment or end-stage renal disease glomerular filtration rate estimate (eGFR) 1.40 mg/dl) in female subjects. 5. Any of the following cardiovascular conditions: myocardial infarction cerebral infarction cardiac surgery or revascularization (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty) unstable angina congestive heart failure (New York Heart Association class III or IV) transient ischemic attack or significant cerebrovascular disease within the last 12 weeks. 6. History of gastrointestinal disease or surgery including intestinal obstruction intestinal ulcer bariatric surgery or girdle surgery gastrointestinal anastomosis or bowel resection. 7. Pregnant women who were breastfeeding. 8. Urinary tract infection within the last 2 weeks. 9. Patients who have taken antibiotics probiotics or gastrointestinal motility medications in the past month. 10. Those who have not signed the informed consent form. 11. Subjects who are in the judgment of the investigator unlikely to comply with the protocol or patients with serious physical or psychological illnesses that could affect the effectiveness or safety of the study.

Design outcomes

Primary

MeasureTime frame
2-hour postprandial blood glucose;Fasting blood glucose;glycosylated hemoglobin;Blood metabolomics;Constitution in Chinese Medicine Questionnaire;Blood proteomics;gut microbiota;

Secondary

MeasureTime frame
Alanine aminotransferase;Uric acid;Serum creatinine;High density lipoprotein cholesterol;Thyroid stimulating hormone;Total cholesterol;urine metabolism;Fasting insulin;Aspartate aminotransferase;triglyceride;blood routine examination;Low density lipoprotein cholesterol;

Countries

China

Contacts

Public ContactWang Wenying

The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University

wwying75@126.com+86 020-81226095

Outcome results

None listed

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