Prediabetic State (IGT)Phase 4XuezhikangNCT06750783
The Effects of Xuezhikang and Atorvastatin on Lipid in Patients With Dyslipidemia and Prediabetes
A Phase 4 study testing Xuezhikang and Atorvastatin in people with Prediabetic State (IGT), run by Beijing Tsinghua Chang Gung Hospital at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetic State (IGT)
- What is being tested?
- Xuezhikang and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 3 sitesChina
- Study dates
- 31 Dec 2024to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beiqijia Community Health Service Center, Changping District, Beijing
Beijing, Beijing Municipality, 102209
yuchen hu, 086-18701636194, 562546856@qq.com
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
lixia jin, phD, 086-13810971045, jlxa00159@btch.edu.cn
wenhui zhao, phD, 086-13810719795, zwha01637@btch.edu.cn
- Recruiting
Xiaotangshan Community Health Service Center, Changping District, Beijing
Beijing, Beijing Municipality
Jiangtao Lu, 086-136813163253, liujiangtaoyx@126.com
About this study
Official title: 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 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.
Read the 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)
- Being tested
- Xuezhikang, Atorvastatin
- Keywords
- XUEZHIKANG, atorvastatin, glucose metabolism, blood glucose fluctuations, diabetes
- Medical subject headings
- Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XuezhikangDrug
The Xuezhikang group takes Xuezhikang at a dose of 600 milligrams twice a day, orally after meals;
AtorvastatinDrug
The atorvastatin group takes atorvastatin 20mg once a day, orally after meals.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin group | Experimental | According to routine clinical practice, patients with dyslipidemia with prediabetes were given atorvastatin at a dose of 20 mg qd； Receives: Drug: Atorvastatin |
| Xuezhikang group | Experimental | The Xuezhikang group takes Xuezhikang at a dose of 600 milligrams twice a day, orally after meals; Receives: Drug: Xuezhikang |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start31 Dec 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic State (IGT)Studies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lixia jin, phD, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750783
- Sponsor's protocol ID
- 2.0 20240725
- Acronym
- Xuezhikang
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effects of Xuezhikang and Atorvastatin on Blood Glucose and Lipid Levels in Patients With Dyslipidemia and Prediabetes
- ClinicalTrials.gov ID
- NCT06750783
- Acronym / sponsor ID
- Xuezhikang / 2.0 20240725
- Conditions
- Prediabetic State (IGT)
- Keywords
- XUEZHIKANG, atorvastatin, glucose metabolism, blood glucose fluctuations, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin group | Experimental | Drug: AtorvastatinAccording to routine clinical practice, patients with dyslipidemia with prediabetes were given atorvastatin at a dose of 20 mg qd； |
| Xuezhikang group | Experimental | Drug: XuezhikangThe Xuezhikang group takes Xuezhikang at a dose of 600 milligrams twice a day, orally after meals; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XuezhikangThe Xuezhikang group takes Xuezhikang at a dose of 600 milligrams twice a day, orally after meals; | Drug | Xuezhikang group |
| AtorvastatinThe atorvastatin group takes atorvastatin 20mg once a day, orally after meals. | Drug | Atorvastatin group |
Primary outcome
Incidence of diabetes
Time frame: 24 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
lixia jin, phD principal investigator
Beijing Tsinghua Changgeng Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xuezhikang and Atorvastatin in people with Prediabetic State (IGT), run by Beijing Tsinghua Chang Gung Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lixia jin, phD (086-13810971045, jlxa00159@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diabetes (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.