Effects of Xuezhikang and Atorvastatin on Lipid Levels in Prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of Xuezhikang and atorvastatin on glucose metabolism in patients with dyslipidemia and prediabetes. It aims to determine how these treatments influence blood glucose fluctuations and the potential mechanisms involved in the progression from prediabetes to diabetes over a 24-week period. The study will involve measuring various metabolic parameters, including lipid levels and insulin resistance, to assess the efficacy of Xuezhikang compared to atorvastatin. It is a multicenter, prospective trial that seeks to provide insights into managing prediabetes effectively.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Beiqijia Community Health Service Center, Changping District, Beijing
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Recruiting
• Xiaotangshan Community Health Service Center, Changping District, Beijing
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: lixia jin, phD — Beijing Tsinghua Changgeng Hospital
• Study coordinator: lixia jin, phD
• Email: jlxa00159@btch.edu.cn
• Phone: 086-13810971045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.