RecruitingPhase 4NCT06750783

The Effects of Xuezhikang and Atorvastatin on Lipid in Patients With Dyslipidemia and Prediabetes

A Randomized Controlled Study on the Effects of Xuezhikang and Atorvastatin on Blood Glucose and Lipid Levels in Patients With Dyslipidemia and Prediabetes


Sponsor

Beijing Tsinghua Chang Gung Hospital

Enrollment

398 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study compares the impact of Xuezhikang and atorvastatin on glucose metabolism to explore the incidence of prediabetes patients developing diabetes after 24 weeks of Xuezhikang use, and by investigating the effect of Xuezhikang on blood glucose fluctuations, discusses the possible mechanisms by which Xuezhikang affects glucose metabolism.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥ 18 years old;
  • No gender restrictions;
  • Definition of pre diabetes: All subjects were tested with 75g OGTT to measure fasting and 2h venous serum glucose and glycosylated hemoglobin. Fasting blood glucose ≥ 6.1 and < 7mmol/L, 2-hour serum glucose ≥ 7.8 and < 11.1mmol/L after glucose load, and glycated hemoglobin<6.5%;
  • Abnormal lipid metabolism: LDL-c ≥ 3.4 mmol/L and<4.9 mmol/L, and TG ≤ 5.6 mmol/L; (2) Non-HDL-c ≥ 4.1mmol/L and<5.7 mmol/L, and TG ≤ 5.6 mmol/L;
  • Voluntarily sign the informed consent form.

Exclusion Criteria11

  • Patients who have met the diagnosis of diabetes;
  • Within 3 months prior to signing the informed consent form, there was an acute coronary syndrome, stroke, or transient ischemic attack.
  • ALT/AST>3 times ULN;
  • Known myopathy, rhabdomyolysis, or creatine kinase levels greater than 4-fold ULN, and not caused by muscle injury;
  • Pregnant or planning to conceive;
  • Have used any lipid-lowering drugs within 3 months;
  • Individuals with allergies/contraindications to Xuezhikang and Atorvastatin.
  • Suffering from any of the following diseases: uncontrolled hyperthyroidism and hypothyroidism, severe heart failure, malignant tumors, hematopoietic system diseases, digestive system diseases affecting digestion and/or absorption function, mental disorders, other serious or unstable physical diseases.
  • History of alcohol or drug abuse or dependence within 3 months prior to joining the trial.
  • Participated in clinical trials of other drugs or devices within 3 months prior to joining the trial.
  • Researchers believe that other situations are not suitable for participating in the experiment.

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Interventions

DRUGXuezhikang

The Xuezhikang group takes Xuezhikang at a dose of 600 milligrams twice a day, orally after meals;

DRUGAtorvastatin

The atorvastatin group takes atorvastatin 20mg once a day, orally after meals.


Locations(3)

Beiqijia Community Health Service Center, Changping District, Beijing

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Xiaotangshan Community Health Service Center, Changping District, Beijing

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06750783