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A cross-sectional study on the relationship between the microbial composition of the digestive tract and the characteristics of tongue coating in type 2 diabetic patients

A cross-sectional study on the relationship between the microbial composition of the digestive tract and the characteristics of tongue coating in type 2 diabetic patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043546
Enrollment
Unknown
Registered
2021-02-21
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-14

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

Conditions

Type 2 diabetes

Interventions

type 2 diabetes and healthy control group:Nil

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy people: 1. Age: 18-65 years old, no gender limit; 2. Physical health: no systemic diseases such as diabetes, HIV infection or genetic diseases, as well as any type of ongoing benign and malignant diseases that may interfere with the evaluation of research objectives; 3. Oral health: no oral diseases, such as leukoplakia, oral lichen planus (OLP), etc.; 4. Sign the informed consent form. Inclusion criteria for patients with type 2 diabetes 1. Age: 40-65 years old, no gender limit; 2. It meets the diagnostic criteria for diabetes and is classified as type 2; 3. Stable blood sugar control in the past 3 months; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with type 1 diabetes or special type diabetes; 2. Patients with acute complications such as ketoacidosis; 3. Systemic use of antibiotics, steroid hormones, cytokines that can stimulate the body's immune system, methotrexate and other immunosuppressants in the past six months; 4. Use probiotics in large doses in the past six months (daily intake > 108cfu); 5. Use local antibiotics (such as mouthwash) in the past 7 days; 6. Systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg; 7. There are obvious untreated oral abscesses, oral precancerous lesions, oral cancer, oral fungal infection, loss of more than 8 teeth and other oral diseases in the mouth; 8. Patients with other serious medical diseases such as tumor, immune system, blood system and other diseases and severe cardiopulmonary insufficiency (New York Heart Association (NYHA) heart function grade >= grade III; lung function GOLD grade >= grade III); 9. Suffering from digestive tract diseases, which can cause accurate chronic diarrhea or severe constipation. 10. Patients with impaired liver and kidney function (ALT and AST are greater than 2 times the upper limit of normal; serum creatinine is greater than the upper limit of normal); 11. Medical history of bowel resection or other gastrointestinal surgery (except appendicitis and hernia surgery) in the past 1 year. 12. History of smoking and alcoholism (except those who have stopped smoking and drinking for >= 3 months); 13. Pregnant women and lactating patients; 14. Mental illness;

Design outcomes

Primary

MeasureTime frame
Microbial composition of the digestive tract;Objectify tongue image parameters;Fecal microorganisms;

Secondary

MeasureTime frame
TCM Syndrome Scale;BMI;WC;Hips;Biochemical Indicators;

Countries

China

Contacts

Public ContactHao Lu

Shanghai University of Traditional Chinese Medicine

Luhao403@163.com+86 13916719260

Outcome results

None listed

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