Type 2 diabetes
Conditions
Interventions
control group:Placebo
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects with type 2 diabetes were diagnosed according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes published by the Diabetology Branch of the Chinese Medical Association. 2. According to the Guidelines for Clinical Research of New Chinese Medicine, Guidelines for Prevention and Treatment of Diabetes in Traditional Chinese Medicine, and the Checklist for Diagnosis of Qi-Yin Deficiency Syndrome of Diabetes, subjects who meet the following diagnostic criteria for Qi-Yin deficiency syndrome have the following symptoms: thirst, fatigue and weakness, boulimia, talking laziness, heat in palms, chest and soles, red tongue with thin white dry fur, thin and weak pulse. 3. Aged 18-65 years. 4. Carotid color ultrasound examination showed CIMT>=1mm. 5. Accompanied by at least 2 macrovascular risk factors: (1) Hypertension: hypertension has been diagnosed in the past and blood pressure is >=130/80mmHg without medication; (2) Dyslipidemia: LDL-C > 2.6mmol/L, accompanied by at least one of the following conditions: non-HDL-C > 3.4mmol/L, or TC > 4.5mmol/L, or TG > 1.7mmol/L, or HDL-C =24kg/m2, or central obesity (waist circumference >=90cm for men and >=85cm for women); (4) Smoking history: continuous or cumulative smoking for more than 6 months, and is still smoking; (5) Aged >=40 years; (6) The course of diabetes is more than 5 years. 6. Volunteer and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Acute metabolic disorders such as diabetic ketoacidosis or severe stress occurred 1 month before screening; 2. Patients who have been diagnosed with coronary heart disease by previous coronary angiography, or whose ECG or clinical findings suggest coronary heart disease, or who have been diagnosed with cerebrovascular accidents, or whose vascular ultrasound suggests peripheral arterial plaque formation, or arterial stenosis or occlusion; 3. Liver function impairment (ALT, AST or ALP higher than 1.5 times of the normal upper limit), renal function impairment (Cr greater than the normal upper limit or eGFR<=60 ml·min^-1·(1.73m^2)^-1; 4. Those suffering from malignant tumours, serious mental illness, or serious medical conditions with a life expectancy of less than 2 years; 5. Prepare pregnant, pregnancy, lactation; 6. Known allergic to Shenqi compound Chinese medicinal materials; 7. Patients in other clinical trials within the last 3 months; 8. The researcher judged that the patient had poor compliance and was not suitable to participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid intima-media thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;HbA1c;Total cholesterol;Triglycerides;Low density lipoprotein cholesterol;High density lipoprotein cholesterol;Fasting insulin;Hemorheology indexes;Vascular internal diameter of the bilateral carotid artery;Peak systolic velocity of the bilateral carotid artery;End diastolic velocity of the bilateral carotid artery;Mean velocity of the bilateral carotid artery;Carotid artery shear stress;Quality of life scale for patients with type 2 diabetes mellitus;Chinese version of diabetes management self-efficacy scale;Chinese version of diabetes management self-efficacy scale; | — |
Countries
China
Contacts
Public ContactXie Chun'guang
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed