Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.
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ClinicalTrials.gov Identifier: NCT03884127 |
Recruitment Status :
Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
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Condition or disease | Intervention/treatment |
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Hyperlipidemia | Drug: Ezetimibe 10mg Drug: Orlistat 120 MG |

Study Type : | Observational |
Estimated Enrollment : | 58 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Analysis of Changes in Intestinal Flora of Hyperlipidemia by Ezetimibe and Orlistat. |
Estimated Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | August 30, 2019 |
Estimated Study Completion Date : | September 30, 2019 |

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.
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Drug: Ezetimibe 10mg
On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
Other Name: lifestyle intervention Drug: Orlistat 120 MG On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
Other Name: lifestyle intervention |
- 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884127
Contact: jin jin, master | +8613319809893 | jinjin@xjmu.edu.cn |
Study Chair: | haoming tian, master | West China Hospital |
Responsible Party: | Jin jin, physician, Fifth Affiliated Hospital of Xinjiang Medical University |
ClinicalTrials.gov Identifier: | NCT03884127 |
Other Study ID Numbers: |
FifthXinjiang |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | March 21, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | After the study is completed, the results will be uploaded |
Supporting Materials: |
Study Protocol Clinical Study Report (CSR) |
Time Frame: | starting 6 months after publication |
Access Criteria: | In excel form,include Baseline data, post-intervention outcomes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
orlistat Ezetimibe Gastrointestinal Microbiome |
Hyperlipidemias Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Orlistat Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Enzyme Inhibitors Anti-Obesity Agents |