HyperlipidemiaNCT03884127
Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.
An observational study of Hyperlipidemia, run by Fifth Affiliated Hospital of Xinjiang Medical University.
Trial summary
At present,the prevalence of hyperlipidemia in Chinese adults is 40.40%,which is related to atherosclerotic cardiovascular disease and diabetes independent risk factors,while increasing the risk of cancer.Lipid metabolism affects the nutritional status of the intestinal epithelium,making the intestine Changes in the… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Ezetimibe 10mg and Orlistat 120 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: On the basis of the community population, the newly diagnosed overweight and hyperlipidemia patients were selected on the basis of baseline investigation
Who may be able to join
- according to the guidelines for the prevention and treatment of dyslipidemia in Chinese adults (revised in 2016), the diagnostic criteria for hyperlipidemia were met, and the stratification criteria for dyslipidemia in Chinese ASCVD primary prevention population were: TC greater than or equal to 6.2mmol/l, ldl-c greater than or equal to 4.1mmol/l, non-hdl-c greater than or equal to 4.9mmol/l, and TG greater than or equal to 2.3mmol/l.(2) newly diagnosed hyperlipidemia patients, BMI 24kg/m2, did not take any lipid-regulating or lipid-lowering drugs within a month;(3) exclude obvious cardiovascular and cerebrovascular diseases by medical history inquiry, physical examination, electrocardiogram examination, skull imaging examination and other data;(4) mental health, after informed consent to participate in the study.
Who cannot join
- (1)acute and chronic liver, renal insufficiency, cholestasis;Acute infectious diseases;Malignant tumor;Thyroid disease;Diseases of the immune system;Patients with gastrointestinal diseases;(2)patients with severe mental illness and cognitive impairment;(3) have used the drugs that have an impact on this study before treatment;(4)allergic to the study of drugs, drug side effects can not be tolerated, do not want to take biological specimens;(5)pregnant and nursing women;6. Did not sign the informed agreement;(7)the use of antibiotics, probiotics and other drugs to interfere with intestinal flora, health products, etc.,in the last 3 months.All experiments were conducted in accordance with relevant legal and institutional guidelines.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of Changes in Intestinal Flora of Hyperlipidemia by Ezetimibe and Orlistat.
At present,the prevalence of hyperlipidemia in Chinese adults is 40.40%,which is related to atherosclerotic cardiovascular disease and diabetes independent risk factors,while increasing the risk of cancer.Lipid metabolism affects the nutritional status of the intestinal epithelium,making the intestine Changes in the microenvironment of the intestinal flora affect the distribution of intestinal flora and eventually lead to bile acid metabolism change.Bile acid is a signal molecule that regulates glucose and lipid and energy metabolism in vivo State.The regulation of intestinal flora may be a new way to treat the imbalance of lipid metabolism,but it is currently sensitive to lipid metabolism the microbiome studies are unclear.In this study, newly diagnosed overweight patients with hyperlipidemia were treated with cholesterol absorption inhibition The drug intervention of ezeomab tablet and orlistat capsule for 12 weeks was observed to observe the changes of intestinal flora and bile acid metabolism after excessive cholesterol and triglyceride production.Clinical screening for the treatment of hyperlipidemia the study provides a reference for bacteria species and prevention and treatment,and provides a research basis for further development of drugs or foods that interfere with lipid metabolism by interfering with intestinal flora.
Read the detailed description
- Research background;Currently, hyperlipidemia in Chinese adults is 40.40%, and is an independent risk factor for atherosclerotic cardiovascular disease and diabetes, as well as increasing the risk of tumor.Hyperlipidemia and intestinal flora are closely related and interact with each other. Intervention of intestinal flora may be one of the ways to treat hyperlipidemia.
- Research objective: to observe the changes of intestinal flora in obese patients with hyperlipidemia who have indications of lipase absorption inhibitor orlistat and cholesterol absorption inhibitor ezeomab and analyze the related influencing factors.
- Research methods and procedures; 3.1 on the basis of community people, on the basis of the baseline survey, choosing a new diagnosis of overweight patients with hyperlipidemia, to carry out the treatment of sexual lifestyle intervention therapy on the basis of oral respectively in accordance with the wheat cloth folding, orlistat capsules for 12 weeks intervention and consistent use of foundation treatment in patients with hyperlipidemia and case-control study.
3.2 on the basis of the indications and voluntary choice of newly diagnosed patients with hyperlipidemia, overweight in the treatment of sexual lifestyle intervention therapy on the basis of, to carry out the drug intervention therapy for 12 weeks, oral respectively according to the fold of wheat and cloth (10 mg, 1 time/day), orlistat capsules (120 mg, 2-3 times/day) to intervene with consistent use of foundation treatment in patients with hyperlipidemia control study.
3.3 telephone follow-up and outpatient follow-up were adopted.All subjects were closely followed up to observe the changes of the patient's condition and whether there were adverse reactions.At the end of 12 weeks of the experiment, blood was drawn on an empty stomach in the morning, and fasting was started after dinner the day before the experiment. The duration of fasting was not less than 8-10 hours, and drinking water was allowed.Three blood samples were collected.
3.4 experiment for the first time in the morning on the day of gathering patients out of fresh 10 g, solid manure into the sterile collection box of oil fecal DNA protection (liquid), the stool specimens in the laboratory is divided into four, then immediately put - 80 ℃ low temperature refrigerator or liquid nitrogen preservation, stay late in intestinal flora DNA extraction.real 4, participants accept blood fat, this is one of the clinical routine physical examination project, orlistat capsules of non-prescription drugs is losing weight, but the existing studies show that after the application of the drug can bring benefit of blood sugar, blood lipid, body weight, and in accordance with the folding mab are clinical commonly used drugs, both has the effect of reducing blood fat, reducing blood fat, bring to significant cardiovascular benefits, and compared with statins, there is no evidence that these drugs can increase the risk of new diabetes.
Subjects can learn about their health conditions in terms of blood lipids through testing. The relevant information obtained from subjects can be used for clinical diagnosis and treatment of hyperlipidemia and contribute to the prevention and treatment of hyperlipidemia.In this study, relevant samples were stored in the endocrine and metabolic diseases laboratory of west China hospital.The researcher promises that the samples will only be used for this study, and will not disclose the samples, patients' clinical information and other data to irrelevant personnel in this study.Clinical data collection (demographic data, measured blood pressure, height, weight, etc.), blood lipids, and intestinal flora monitoring were all undertaken by researchers.The registration fee incurred on the day of inspection shall be borne by the researcher, and the meal fee and transportation fee incurred on the day shall be subsidized to a certain extent (RMB fifty). The financial burden of the subject will not be increased during the whole experiment.
- Alternative methods of diagnosis and treatment. According to the 2016 Chinese adult guidelines for the prevention and treatment of dysmatosis in Chinese adults (revised version in 2016), subjects may choose other kinds of appropriate drugs, such as statins, betins, niacin, bile acid chelating agents, etc., at their own expense.
- Conditions
- Hyperlipidemia
- Being tested
- Ezetimibe 10mg, Orlistat 120 MG
- Keywords
- orlistat, Ezetimibe, Gastrointestinal Microbiome
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe 10mgDrug
Also called lifestyle intervention
On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
Orlistat 120 MGDrug
Also called lifestyle intervention
On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| hyperlipidaemia | On the basis of the intervention of therapeutic sexual life style, a case control study was conducted on the intervention of oral ezetimibe tablet and orlistat capsule for 12 weeks and hyperlipidemia patients who persisted in the use of basic treatment. Receives: Drug: Ezetimibe 10mg; Drug: Orlistat 120 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood lipid
Triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol
Measured: enroll(0 month)，finish(3 month)
bile acid
total bile acid
Measured: enroll(0 month)，finish(3 month)
Gastrointestinal flora
Firmicutes, bacteroides
Measured: enroll(0 month)，finish(3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital of Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Principal investigator, Jin jin, Fifth Affiliated Hospital of Xinjiang Medical University
- Investigators
- haoming tian, master, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884127
- Sponsor's protocol ID
- FifthXinjiang
- Status last verified
- Feb 2019
- First submitted
- 19 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, the results will be uploaded
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Changes in Intestinal Flora of Hyperlipidemia by Ezetimibe and Orlistat.
- ClinicalTrials.gov ID
- NCT03884127
- Acronym / sponsor ID
- FifthXinjiang
- Conditions
- Hyperlipidemia
- Keywords
- orlistat, Ezetimibe, Gastrointestinal Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital of Xinjiang Medical UniversityUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 21 Mar 2019 (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.
At present,the prevalence of hyperlipidemia in Chinese adults is 40.40%,which is related to atherosclerotic cardiovascular disease and diabetes independent risk factors,while increasing the risk of cancer.Lipid metabolism affects the nutritional status of the intestinal epithelium,making the intestine Changes in the microenvironment of the intestinal flora affect the distribution of intestinal flora and eventually lead to bile acid metabolism change.Bile acid is a signal molecule that regulates glucose and lipid and energy metabolism in vivo State.The regulation of intestinal flora may be a new way to treat the imbalance of lipid metabolism,but it is currently sensitive to lipid metabolism the microbiome studies are unclear.In this study, newly diagnosed overweight patients with hyperlipidemia were treated with cholesterol absorption inhibition The drug intervention of ezeomab tablet and orlistat capsule for 12 weeks was observed to observe the changes of intestinal flora and bile acid metabolism after excessive cholesterol and triglyceride production.Clinical screening for the treatment of hyperlipidemia the study provides a reference for bacteria species and prevention and treatment,and provides a research basis for further development of drugs or foods that interfere with lipid metabolism by interfering with intestinal flora.
Detailed description
- Research background;Currently, hyperlipidemia in Chinese adults is 40.40%, and is an independent risk factor for atherosclerotic cardiovascular disease and diabetes, as well as increasing the risk of tumor.Hyperlipidemia and intestinal flora are closely related and interact with each other. Intervention of intestinal flora may be one of the ways to treat hyperlipidemia.
- Research objective: to observe the changes of intestinal flora in obese patients with hyperlipidemia who have indications of lipase absorption inhibitor orlistat and cholesterol absorption inhibitor ezeomab and analyze the related influencing factors.
- Research methods and procedures; 3.1 on the basis of community people, on the basis of the baseline survey, choosing a new diagnosis of overweight patients with hyperlipidemia, to carry out the treatment of sexual lifestyle intervention therapy on the basis of oral respectively in accordance with the wheat cloth folding, orlistat capsules for 12 weeks intervention and consistent use of foundation treatment in patients with hyperlipidemia and case-control study.
3.2 on the basis of the indications and voluntary choice of newly diagnosed patients with hyperlipidemia, overweight in the treatment of sexual lifestyle intervention therapy on the basis of, to carry out the drug intervention therapy for 12 weeks, oral respectively according to the fold of wheat and cloth (10 mg, 1 time/day), orlistat capsules (120 mg, 2-3 times/day) to intervene with consistent use of foundation treatment in patients with hyperlipidemia control study.
3.3 telephone follow-up and outpatient follow-up were adopted.All subjects were closely followed up to observe the changes of the patient's condition and whether there were adverse reactions.At the end of 12 weeks of the experiment, blood was drawn on an empty stomach in the morning, and fasting was started after dinner the day before the experiment. The duration of fasting was not less than 8-10 hours, and drinking water was allowed.Three blood samples were collected.
3.4 experiment for the first time in the morning on the day of gathering patients out of fresh 10 g, solid manure into the sterile collection box of oil fecal DNA protection (liquid), the stool specimens in the laboratory is divided into four, then immediately put - 80 ℃ low temperature refrigerator or liquid nitrogen preservation, stay late in intestinal flora DNA extraction.real 4, participants accept blood fat, this is one of the clinical routine physical examination project, orlistat capsules of non-prescription drugs is losing weight, but the existing studies show that after the application of the drug can bring benefit of blood sugar, blood lipid, body weight, and in accordance with the folding mab are clinical commonly used drugs, both has the effect of reducing blood fat, reducing blood fat, bring to significant cardiovascular benefits, and compared with statins, there is no evidence that these drugs can increase the risk of new diabetes.
Subjects can learn about their health conditions in terms of blood lipids through testing. The relevant information obtained from subjects can be used for clinical diagnosis and treatment of hyperlipidemia and contribute to the prevention and treatment of hyperlipidemia.In this study, relevant samples were stored in the endocrine and metabolic diseases laboratory of west China hospital.The researcher promises that the samples will only be used for this study, and will not disclose the samples, patients' clinical information and other data to irrelevant personnel in this study.Clinical data collection (demographic data, measured blood pressure, height, weight, etc.), blood lipids, and intestinal flora monitoring were all undertaken by researchers.The registration fee incurred on the day of inspection shall be borne by the researcher, and the meal fee and transportation fee incurred on the day shall be subsidized to a certain extent (RMB fifty). The financial burden of the subject will not be increased during the whole experiment.
- Alternative methods of diagnosis and treatment. According to the 2016 Chinese adult guidelines for the prevention and treatment of dysmatosis in Chinese adults (revised version in 2016), subjects may choose other kinds of appropriate drugs, such as statins, betins, niacin, bile acid chelating agents, etc., at their own expense.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperlipidaemia | – | Drug: Ezetimibe 10mg, Drug: Orlistat 120 MGOn the basis of the intervention of therapeutic sexual life style, a case control study was conducted on the intervention of oral ezetimibe tablet and orlistat capsule for 12 weeks and hyperlipidemia patients who persisted in the use of basic treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- On the basis of the community population, the newly diagnosed overweight and hyperlipidemia patients were selected on the basis of baseline investigation
Key inclusion criteria (1 listed)
- according to the guidelines for the prevention and treatment of dyslipidemia in Chinese adults (revised in 2016), the diagnostic criteria for hyperlipidemia were met, and the stratification criteria for dyslipidemia in Chinese ASCVD primary prevention population were: TC greater than or equal to 6.2mmol/l, ldl-c greater than or equal to 4.1mmol/l, non-hdl-c greater than or equal to 4.9mmol/l, and TG greater than or equal to 2.3mmol/l.(2) newly diagnosed hyperlipidemia patients, BMI 24kg/m2, did not take any lipid-regulating or lipid-lowering drugs within a month;(3) exclude obvious cardiovascular and cerebrovascular diseases by medical history inquiry, physical examination, electrocardiogram examination, skull imaging examination and other data;(4) mental health, after informed consent to participate in the study.
Key exclusion criteria (1 listed)
- (1)acute and chronic liver, renal insufficiency, cholestasis;Acute infectious diseases;Malignant tumor;Thyroid disease;Diseases of the immune system;Patients with gastrointestinal diseases;(2)patients with severe mental illness and cognitive impairment;(3) have used the drugs that have an impact on this study before treatment;(4)allergic to the study of drugs, drug side effects can not be tolerated, do not want to take biological specimens;(5)pregnant and nursing women;6. Did not sign the informed agreement;(7)the use of antibiotics, probiotics and other drugs to interfere with intestinal flora, health products, etc.,in the last 3 months.All experiments were conducted in accordance with relevant legal and institutional guidelines.
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 |
|---|---|---|
| Ezetimibe 10mgAlso: lifestyle interventionOn the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks | Drug | hyperlipidaemia |
| Orlistat 120 MGAlso: lifestyle interventionOn the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks | Drug | hyperlipidaemia |
Primary outcome
blood lipid
Time frame: enroll(0 month)，finish(3 month)
Triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol
bile acid
Time frame: enroll(0 month)，finish(3 month)
total bile acid
Gastrointestinal flora
Time frame: enroll(0 month)，finish(3 month)
Firmicutes, bacteroides
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: Yes. After the study is completed, the results will be uploaded
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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. This study is not recruiting at the moment.
haoming tian, master study chair
West China Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, run by Fifth Affiliated Hospital of Xinjiang Medical University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jin jin, master (+8613319809893, jinjin@xjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood lipid (time frame: enroll(0 month)，finish(3 month)). The study lists 3 primary outcomes in all. 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 21 Mar 2019.