Prediabetes with obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria of obesity and prediabetes at the same time; (2) Age 18-64 years old; (3) Be able to correctly describe their wishes, voluntarily fill in the informed consent form, and agree to participate in clinical trials. Note: The above three items must be met at the same time.
Exclusion criteria
Exclusion criteria: (1) Secondary obesity caused by hypothyroidism, Cushing's syndrome, hyperadrenocorticism, polycystic ovary syndrome, etc.; (2) Suffering from hyperthyroidism, endocrine tumors, and extensive liver damage resulting in impaired glucose regulation; (3) Drugs that have a significant impact on body weight or blood sugar in the past 3 months: hormonal drugs (glucocorticoids (such as dexamethasone, hydrocortisone, prednisone, methylprednisone, etc., sex hormones, growth hormone, etc.), antipsychotics, antidepressants, antiseizure drugs, hormonal contraceptives;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in the subject's weight from baseline at the end of the 8th week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in subject's weight from baseline;Percentage of patients who lost more than 5% of their body weight from baseline;Percentage of patients who lost more than 7% of their body weight from baseline;Change from baseline in fasting blood glucose (FPG), blood glucose value (2hPG) after 2 hours, glycated hemoglobin (HbA1c) and percentage of patients who returned to normal values;Changes in body mass index (BMI), waist circumference, waist-to-hip ratio (WHR), waist-to-height ratio (WHtR), and blood pressure (BP) from baseline;The change value of appetite VAS score from baseline;Changes from baseline in fasting blood insulin (FINS), insulin after 2 hours, fasting C-peptide, C-peptide after 2 hours, insulin resistance index (HOMA-IR), and pancreatic islet ß cell function (HOMA-ß).;Total cholesterol (TC), trisglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol Changes from baseline in alcohol (HDL-C), blood uric acid (UA), c-reactive protein, leptin, adiponectin, and fatty acids;The change from baseline in the score of the European Five-Dimensional Health Scale (EQ-5D-5L).;The change of PHQ-4 score from baseline;Proportion of progression to diabetes at one year of enrollment;Baseline expectancy evaluation, acupuncture trust evaluation, acupuncture blinding effect evaluation, adherence evaluation, Diet and exercise evaluation; | — |
Countries
China
Contacts
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine