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)
Conditions
Interventions
Control group:Lifestyle intervention
Experimental group:Administration of "Phlegm-Dampness Constitution Regulating Formula" granules in addition to lifestyle intervention.
Sponsors
National Institute of TCM Constitution and Preventive Medicine, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1)Subjects meeting the diagnostic criteria for the target population; the pre-clinical phlegm-dampness constitution group (individuals with a phlegm-dampness constitution combined with pre-type 2 diabetes and borderline elevated blood lipids) must simultaneously fulfill the criteria for phlegm-dampness constitution, pre-type 2 diabetes diagnosis, and borderline elevated blood lipids diagnosis. 2)Aged 18-60 years, male or female. 3)Voluntarily signed informed consent and willing to cooperate with the researchers.
Exclusion criteria
Exclusion criteria: 1)Subjects with a pronounced combined constitution. 2)Women who are breastfeeding, pregnant, or planning to become pregnant. 3)Subjects with other metabolic diseases, cardiovascular or cerebrovascular diseases, or other definitively diagnosed diseases of the heart, liver, kidney, endocrine system, blood, autoimmune diseases, tumors, or severe mental illness. 4)Carriers of various viruses or bacteria, and patients with a history of infectious diseases. 5)Subjects with a history of drug abuse or drug addiction. 6)Subjects who used hypoglycemic drugs, lipid-lowering drugs, or glucocorticoids within one month prior to sampling. 7)Subjects who participated in other clinical drug trials within the past 3 months. 8)Subjects with a history of surgery or severe trauma within the past month. 9)Subjects with poor compliance and any other conditions deemed unsuitable for the study by the researchers. 10)Subjects who have used antibiotics within the past month, or women who are currently menstruating, will be enrolled at a later suitable time. 11)Subjects with thyroid diseases requiring medication, such as hyperthyroidism or hypothyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Homeostasis Model Assessment of ß-cell function (HOMA-ß);Matsuda Index;Triglyceride-Glucose 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 Postprandial Glucose (OGTT-2h PG);2-hour Postprandial Insulin (OGTT-2h INS);2-hour Postprandial C-peptide (OGTT-2h C-P);1-hour Postprandial Glucose (OGTT-1h PG);1-hour Postprandial Insulin (OGTT-1h INS);1-hour Postprandial C-peptide (OGTT-1h C-P);30-minute Postprandial Glucose (OGTT-30min PG;30-minute Postprandial Insulin (OGTT-30min INS);30-minute Postprandial C-peptide (OGTT-30min C-P);Phlegm-Dampness Constitution Raw Score;Phlegm-Dampness Constitution Transformed Score;Phlegm-Dampness Constitution Item Score;Body Mass Index (BMI);Waist Circumference (WC);Hip Circumference (HC);Waist-to-Hip Ratio (WHR);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
Outcome results
None listed