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

NCT06750783 | Recruiting Phase 4

• 1 other identifier: 2.0 20240725
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 3

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.

Conditions

Prediabetic State (IGT)

Keywords

XUEZHIKANG; atorvastatin; glucose metabolism; blood glucose fluctuations; diabetes

Outcome Measures

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).

  24 weeks

Study Arms (2)

Atorvastatin group

EXPERIMENTAL

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

Drug: Atorvastatin

Xuezhikang group

EXPERIMENTAL

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

Drug: Xuezhikang

Interventions

Xuezhikang DRUG

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

Xuezhikang group

Atorvastatin DRUG

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

Atorvastatin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (3)

Beiqijia Community Health Service Center, Changping District, Beijing

Beijing, Beijing Municipality, 102209, China

RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

Xiaotangshan Community Health Service Center, Changping District, Beijing

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus

Interventions

xuezhikang; Atorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• lixia jin, phD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lixia jin, phD

CONTACT

086-13810971045; jlxa00159@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: December 31, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)