Effects of Xuezhikang vs Pravastatin on triglyceride level in patients with Type 2 Diabetes Mellitus and Dyslipidemia: a multicenter, prospective, randomized controlled study

Phase 4

Recruiting

• Conditions: Type 2 Diabetes Mellitus with Dyslipidemia

• Registration Number: ITMCTR2100004887
• Lead Sponsor: The Second Xiangya Hospital of Central South University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged >= 18 years.
2. Diagnosed type 2 diabetes patients, according to the Diabetes Medical Diagnosis and Treatment Standards established by the American Diabetes Association (ADA) in 2020, need to meet any of the following criteria:
(1) Fasting plasma glucose >= 7.0mmol/L, fasting state means no calorie intake for at least 8 hours;
(2) OGTT 2 hours plasma glucose >= 11.1mmol/L, OGTT method according to WHO standard, oral anhydrous glucose powder 75g;
(3) HbA1c>=6.5%, HbA1c detection adopts NGSP and DCCT certification methods;
(4) Patients with typical symptoms of hyperglycemia or risk of hyperglycemia, random blood glucose >= 11.1mmol/L, and treatment of diabetes under the guidance of an endocrinologist during the study period.
3. At least one of the following conditions exists:
(1) History of type 2 diabetes >=10 years;
(2) Smoking;
(3) Obesity [BMI >= 28Kg/m^2, or waist circumference>=90cm (male) or >= 85cm (female)];
(4) Hypertension;
(5) Fasting HDL-C < 1.0mmol/L or LDL-C >= 2.6mmol/L in the past four weeks.
4. Abnormal blood lipids in the past 4 weeks must meet the following two conditions at the same time:
(1) 1.7mmol/L <= Fasting TG < 5.6mmol/L;
(2) 1.8mmol/L <= fasting LDL-C < 4.9mmol/L.
5. During the study period, the selected patients are willing to accept and comply with dietary education.
6. The patient must be able to comply with regular visits, treatment plans and all laboratory tests.
7. Sign informed consent and take the test voluntarily.

Exclusion Criteria

1. Patients suffering from atherosclerotic cardiovascular diseases, including coronary atherosclerotic heart disease, ischemic stroke, transient ischemic attack, peripheral artery disease, etc.;
2. Patients who have taken lipid-lowering drugs in the past three months;
3. Diabetic patients who have not controlled their blood sugar well, that is, HbA1c%>=8.0%;
4. Active hepatitis or unexplained continuous increase in serum aminotransferase or serum aminotransferase level greater than 3 times the upper limit of normal;
5. Patients with myopathy or increased serum creatine kinase that cannot be explained by muscle damage (greater than 5 times the upper limit of normal);
6. Patients who are allergic to Xuezhikang or pravastatin, and take glucocorticoids or contraceptives for a long time;
7. In the acute stage of various infectious diseases, suffering from hyperthyroidism or hypothyroidism, acute cerebrovascular disease, severe heart or renal insufficiency ( > CKD3 stage), malignant tumor, hematopoietic system disease, autoimmune system disease, severe impact Patients with digestive or/and absorptive digestive diseases, mental diseases, severe or unstable physical diseases;
8. Abuse or dependence on alcohol or drugs in the past three months;
9. Patients who have participated in clinical trials of other drugs in the past three months;
10. The researcher believes that there are other situations that are not suitable for participating in the trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rine routine;Plasma Glucose (PG) levels;Insulin levels;Fasting HbA1c% levels;Blood lipid routine;Blood routine;Blood lipids complete set ;Hypersensitive C-reactive protein(hs-CRP) ;Fasting blood lipid routine;

Secondary Outcome Measures

Name	Time	Method
Renal function test;Hepatic function test;Creatine kinase;