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A Cross-Sectional Study on the Mechanism of Insulin Resistance Characteristics in the Preclinical Stage of Phlegm-Damp Constitution Based on Exosomal miRNA-155 Regulating PPARG

Mechanism Study of "Tanshi Tiaoti Formula" in Early Intervention of Insulin Resistance-Related Metabolic Diseases Based on Exosomal miRNA-155 Regulating PPARG

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001289
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Insulin resistance-related metabolic diseases (focusing on the preclinical stage of phlegm-damp constitution: phlegm-damp constitution combined with prediabetes and borderline elevated blood lipids)

Interventions

Balanced Constitution Group (Healthy Population):No intervention measures
only one-time data collection, index detection, and biological sample preservation are completed at enrollment
Preclinical Phlegm-Damp Constitution Group (Phlegm-Damp Constitution combined with Prediabetes and Borderline Elevated Blood Lipids):No intervention measures

Sponsors

National Institute of TCM Constitution and Preventive Medicine, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Meet the inclusion diagnostic criteria, where the Balanced Constitution group (healthy population) must meet the balanced constitution assessment criteria and have normal blood glucose and lipid levels; the Phlegm-Dampness Constitution Preclinical Stage group (individuals with phlegm-dampness constitution combined with prediabetes for type 2 diabetes and borderline elevated blood lipids) must simultaneously meet the diagnostic criteria for phlegm-dampness constitution, the diagnostic criteria for prediabetes (type 2 diabetes), and the criteria for borderline elevated blood lipids. 2) Age 18–60 years, male or female; 3) Voluntarily sign the informed consent form and be willing to cooperate with the investigators.

Exclusion criteria

Exclusion criteria: 1.Those with obvious combined constitutions (not a single balanced constitution or a single phlegm-dampness constitution); 2. Those who are breastfeeding, pregnant or have plans to become pregnant; 3. Those with concurrent metabolic diseases, cardiovascular and cerebrovascular diseases, or with a clear diagnosis of heart, liver, kidney, endocrine, blood, autoimmune diseases, tumors and severe mental disorders; 4. Those who are carriers of various viruses or bacteria or have a history of infectious diseases; 5. Those with a history of drug abuse or drug use; 6. Those who have used hypoglycemic drugs, lipid-lowering drugs or glucocorticoids within one month before sampling; 7.3 Those who have participated in clinical trials of other drugs within the past three months; 8. Those who have had surgery or a history of severe trauma within the past month; 9. Poor compliance, or other circumstances that the researchers assess as unsuitable for participation in this study; 10. Subjects who have used antibiotics within the past month or are currently menstruating (to be enrolled at a later date but temporarily excluded).

Design outcomes

Primary

MeasureTime frame
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR);

Secondary

MeasureTime frame
HOMA-ß;Matsuda index;TyG index;Fasting Plasma Glucose (FPG);Fasting Insulin (FINS);Glycated Hemoglobin (HbA1c);Fasting C-Peptide (FC-P);Triglycerides (TG);Total Cholesterol (TC);Low-Density Lipoprotein Cholesterol (LDL-C);High-Density Lipoprotein Cholesterol (HDL-C);Apolipoprotein A (ApoA);Apolipoprotein B (ApoB);2-Hour Post-Load Plasma Glucose (OGTT-2h PG);2-Hour Post-Load Insulin (OGTT-2h INS);2-Hour Post-Load C-Peptide (OGTT-2h C-P);1-Hour Post-Load Plasma Glucose (OGTT-1h PG);1-Hour Post-Load Insulin (OGTT-1h INS);1-Hour Post-Load C-Peptide (OGTT-1h C-P);30-Minute Post-Load Plasma Glucose (OGTT-30min PG);30-Minute Post-Load Insulin (OGTT-30min INS);30-Minute Post-Load C-Peptide (OGTT-30min C-P);Phlegm-Dampness Constitution Raw Score;Phlegm-Dampness Constitution Transformed Score;Phlegm-Dampness Constitution Item Scores;BMI;Waist Circumference;Hip Circumference;Waist-To-Hip Ratio;Exosomal miRNA-155 Level;PPARG Target Gene Expression Level;PPARG Target Protein Level;

Countries

P.R. China

Contacts

Public ContactSun Ziwei

Beijing University of Chinese Medicine

ziweisun@163.com010-64286766

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026