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

NCT ID: NCT06750783

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-03-31

Brief 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.

Detailed Description

The development of chronic complications of diabetes is not only closely related to HbA1c, but may also correlate with blood glucose fluctuations, and the mechanisms may be related to including oxidative stress, inflammation, endothelial dysfunction, and altered gene expression. Glycemic fluctuations are not only important in diabetic patients, but also in prediabetic patients where changes have already been observed. Intraday glucose fluctuations in patients with abnormal glucose tolerance are already significantly higher, up to 50% higher than in those with normal glucose regulation. The study of blood glucose fluctuation and pancreatic function found that the level of blood glucose fluctuation in normal glucose regulators, pre-diabetic and gestational diabetic patients was negatively correlated with early phase insulin secretion function, indicating that those with large blood glucose fluctuation have relatively poor pancreatic function, suggesting that early changes in pancreatic function can affect blood glucose fluctuation. Therefore, the authors believe that blood glucose fluctuation may be significant for the progression of pre-diabetes to diabetes, and can be used for early warning of diabetes. In this study, we investigated the lipid-lowering effect of the natural lipid-regulating drug Lipotecan and its effect on insulin resistance, blood glucose fluctuation and new-onset diabetes in patients with dyslipidemia with prediabetes.

This is a multicenter, prospective, open-label, superiority randomized controlled study to explore the effects of applying Lipitor (dose 600mg bid) versus atorvastatin (20mg qd) on the incidence of new-onset diabetes mellitus, glucose fluctuation, and the differences in the pre and post changes in lipid profiles in patients with dyslipidemia with pre-diabetes mellitus, respectively.

All subjects were informed and the study was intended to be approved by the Ethics Committee of Beijing Tsinghua Changgeng Hospital, Tsinghua University.

Hypothesis: Patients with prediabetes combined with dyslipidemia were orally administered Lipitor (600 mg bid).The rate of new-onset diabetes is lower than that of atorvastatin (200 mg qd) treatment group.

The Lipocon group will receive Lipocon at a dose of 600mg twice daily with meals, and the Atorvastatin group will receive Atorvastatin 20mg once daily orally with meals.All patients will be treated for 24 weeks. Patients are not allowed to use other lipid-lowering medications throughout the study period.

All subjects will be required to take a cell phone related medical history, including general condition, past medical history, current medical history and history of drug use. The laboratory collected blood specimens from the subjects in accordance with the clinical diagnosis and treatment, tested glycated hemoglobin, glucose, insulin and c-peptide by oral glucose tolerance test in fasting, 0.5h, 1h and 2h after sugar water, and monitored the basic liver function, renal function, lipid profile and creatine kinase of all subjects, and the venous blood taken was strictly verified by the laboratory departments of the respective centers.

Conditions

Prediabetic State (IGT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin group

According to routine clinical practice, patients with dyslipidemia with prediabetes were given atorvastatin at a dose of 20 mg qd；

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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

Xuezhikang group

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

Group Type: EXPERIMENTAL

Xuezhikang

Intervention Type: DRUG

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

Interventions

Xuezhikang

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

Intervention Type: DRUG

Atorvastatin

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lixia jin, phD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Changgeng Hospital

Locations

Beiqijia Community Health Service Center, Changping District, Beijing

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Xiaotangshan Community Health Service Center, Changping District, Beijing

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

lixia jin, phD

Role: CONTACT

jlxa00159@btch.edu.cn

086-13810971045

Facility Contacts

yuchen hu

Role: primary

562546856@qq.com

086-18701636194

lixia jin, phD

Role: primary

jlxa00159@btch.edu.cn

086-13810971045

wenhui zhao, phD

Role: backup

zwha01637@btch.edu.cn

086-13810719795

Jiangtao Lu

Role: primary

liujiangtaoyx@126.com

086-136813163253

Other Identifiers

2.0 20240725

Identifier Type: -

Identifier Source: org_study_id