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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tsinghua Chang Gung Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xuezhikang

    Drug

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

  • Atorvastatin

    Drug

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

Treatment groups

398 Participants
are divided into 2 treatment groups
Group A: Atorvastatin groupExperimental treatment 1 intervention
Group B: Xuezhikang groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of diabetes

Collect blood samples from subjects, measure patients' glycated hemoglobin, and detect blood glucose levels at fasting, 0.5 hours, 1 hour, and 2 hours after drinking 75g glucose water through the oral glucose tolerance test (OGTT) (the time is calculated from the start of drinking the glucose water).

Time frame
24 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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