The Effects of Xuezhikang and Atorvastatin on Lipid in Patients With Dyslipidemia and Prediabetes (NCT06750783) | Clinical Trial Compass
RecruitingPhase 4
The Effects of Xuezhikang and Atorvastatin on Lipid in Patients With Dyslipidemia and Prediabetes
China398 participantsStarted 2024-12-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 tri…