- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03884127
Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.
Analysis of Changes in Intestinal Flora of Hyperlipidemia by Ezetimibe and Orlistat.
Study Overview
Status
Conditions
Intervention / Treatment
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.
5. 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: jin jin, master
- Phone Number: +8613319809893
- Email: jinjin@xjmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
(1) 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.
Exclusion Criteria:
(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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
Other Names:
On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood lipid
Time Frame: enroll(0 month),finish(3 month)
|
Triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol
|
enroll(0 month),finish(3 month)
|
bile acid
Time Frame: enroll(0 month),finish(3 month)
|
total bile acid
|
enroll(0 month),finish(3 month)
|
Gastrointestinal flora
Time Frame: enroll(0 month),finish(3 month)
|
Firmicutes, bacteroides
|
enroll(0 month),finish(3 month)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: haoming tian, master, West China Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FifthXinjiang
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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