Type 2 Diabetes Mellitus
Conditions
Interventions
Control group:Atorvastatin Calcium Tablets + Placebo for Danggui Liuhuang Decoction
Treatment group:Atorvastatin Calcium Tablets + Danggui Liuhuang Decoction
Sponsors
Putuo Hospital Shanghai University of Traditonal Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old and < 70 years old; (2) A clear diagnosis of type 2 diabetes with fasting plasma glucose (FPG) = 9.0 mmol/L and glycated hemoglobin (HbA1C) < 8.5%; (3) Meets the traditional Chinese medicine syndrome type of "Yin deficiency and Yang excess"; (4) Has not taken lipid-lowering drugs in the past and belongs to the high-risk population for atherosclerotic cardiovascular disease (ASCVD) defined according to the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)" and the "Chinese Guidelines for the Management of Dyslipidemia (2023)" as meeting any of the following conditions: a. LDL-C = 4.9 mmol/L or TC = 7.2 mmol/L; b. Age = 40 years old; c. Having 3 risk factors or combined target organ damage main risk factors: dyslipidemia smoking obesity early family history of coronary heart disease. Target organ damage: proteinuria kidney damage left ventricular hypertrophy or retinopathy; (5) If there is a history of hypertension blood pressure should be controlled within 120-139/70-89 mmHg with regular medication use in the past 2 months and no adjustment in the antihypertensive medication regimen; (6) Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those with a history of ASCVD; (2) Triglycerides (TG) = 5.7 mmol/L; (3) Known allergy to the study medication or individuals with multiple drug allergies; (4) Previously diagnosed with type 1 diabetes; (5) Previously diagnosed with severe arrhythmias such as recurrent and symptomatic ventricular tachycardia atrial fibrillation with rapid ventricular rate previously diagnosed with New York Heart Association (NYHA) Class III-IV heart function; (6) Previously diagnosed with nephrotic syndrome severe liver disease Cushing's syndrome or other diseases that significantly affect lipid levels. Estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73m^2 (calculated using the MDRD formula); Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) exceeding twice the upper limit of normal or total bilirubin exceeding 1.5 times the upper limit of normal; Creatine Kinase exceeding three times the upper limit of normal; (7) Hyperthyroidism or hypothyroidism defined as thyroid-stimulating hormone below the lower limit of normal or exceeding 1.5 times the upper limit of normal; (8) History of malignant tumor within 5 years prior to screening; (9) History of major surgery within 3 months prior to screening or planning to undergo major surgery during the study period; (10) Long-term continuous or repeated use of systemic glucocorticoids within 3 months prior to screening; (11) Having active infectious diseases psychiatric disorders being pregnant or breastfeeding at the time of screening or randomization etc. as determined by the investigator to be unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-Mediated Dilation (FMD); | — |
Secondary
| Measure | Time frame |
|---|---|
| glucose metabolism-related indicators;Lipid Metabolism-Related Indicators;Traditional Chinese Medicine Syndrome Scoring;lipid metabolism-related indicators;Carotid Intima-Media Thickness; | — |
Countries
China
Contacts
Public ContactTao Lei
Putuo Hospital Shanghai University of Traditonal Chinese Medicine
Outcome results
None listed