prediabetes
Conditions
Interventions
Treatment group:Treatment with Kaiyu Jiangzhuo Tongzhi prescription, usage and dosage: 1 bag/time, 2 times/day.
Control group:Treatment with placebo, dosage: 1 bag/time, 2 times/day
Sponsors
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Meet the western medical diagnostic criteria for prediabetes: IFG: fasting venous plasma glucose >= 6.1mmol/L, and = 7.8mmol/L, and = 6.1mmol/L and = 7.8mmol/L, and = 24.0kg/m2 and/or waist circumference >= 90cm for men and >= 85cm for women; 5. Those who have voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with diagnosed type 1 diabetes, type 2 diabetes, gestational diabetes, secondary diabetes and other special types of diabetes; 2. People who used antidiabetic drugs continuously within the past 3 months; 3. Patients with severe cardiovascular and cerebrovascular diseases, other serious diseases, mental disorders or behavioral inhibition; 4. Patients with severe hypertension: systolic blood pressure > 160 mmHg or diastolic blood pressure > 100mmHg; 5. Severe hepatic and renal dysfunction (ALT > 3 times the upper limit of normal, eGFR 4.5 mmol/L; 9. Allergic to known ingredients of study drugs or with allergic constitution; 10. Pregnant or lactating women or those with recent childbearing plans; 11. Currently or within the past 3 months participating in another clinical trial; 12. According to the investigator's judgment, the patient was not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of diabetes at week 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| The conversion rate of normal glucose tolerance at the end of 48 weeks;Glycosylated hemoglobin (HbA1c);Fasting blood glucose;2h postprandial blood glucose;Fasting insulin;Insulin resistance index (HOMA-IR);Cholesterol (TC);Triglycerides (TG);High density lipoprotein (HDL-C);Low density lipoprotein (LDL-C);Body mass index;Waist circumference;Diabetic symptom grading quantitative table was used for assessment;Body Composition Analysis;Diabetes Risk Score; | — |
Countries
China
Contacts
Public ContactJixiang Ren
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Outcome results
None listed