Effects of Xuezhikang and Atorvastatin on Lipid Levels in Prediabetes
A Randomized Controlled Study on the Effects of Xuezhikang and Atorvastatin on Blood Glucose and Lipid Levels in Patients With Dyslipidemia and Prediabetes
This study is testing whether Xuezhikang or atorvastatin can help people with prediabetes and high cholesterol manage their blood sugar and cholesterol levels better over 24 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 398 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT06750783 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with prediabetes and abnormal lipid metabolism.
Not a fit: Patients who have already been diagnosed with diabetes or have certain acute medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer new treatment options for managing lipid levels and preventing the progression of prediabetes to diabetes.
How similar studies have performed: Other studies have shown promising results with similar approaches in managing dyslipidemia and prediabetes, indicating that this research builds on existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.