Working… Menu

Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03884127
Recruitment Status : Unknown
Verified February 2019 by Jin jin, Fifth Affiliated Hospital of Xinjiang Medical University.
Recruitment status was:  Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
West China Hospital
Information provided by (Responsible Party):
Jin jin, Fifth Affiliated Hospital of Xinjiang Medical University

Brief 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 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.

Condition or disease Intervention/treatment
Hyperlipidemia Drug: Ezetimibe 10mg Drug: Orlistat 120 MG

Show Show detailed description

Layout table for study information
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.
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

Primary Outcome Measures :
  1. blood lipid [ Time Frame: enroll(0 month),finish(3 month) ]
    Triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol

  2. bile acid [ Time Frame: enroll(0 month),finish(3 month) ]
    total bile acid

  3. Gastrointestinal flora [ Time Frame: enroll(0 month),finish(3 month) ]
    Firmicutes, bacteroides

Biospecimen Retention:   Samples With DNA
Fecal bacteria DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
On the basis of the community population, the newly diagnosed overweight and hyperlipidemia patients were selected on the basis of baseline investigation

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03884127

Layout table for location contacts
Contact: jin jin, master +8613319809893

Sponsors and Collaborators
Fifth Affiliated Hospital of Xinjiang Medical University
West China Hospital
Layout table for investigator information
Study Chair: haoming tian, master West China Hospital
Layout table for additonal information
Responsible Party: Jin jin, physician, Fifth Affiliated Hospital of Xinjiang Medical University 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

Layout table for additional information
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
Keywords provided by Jin jin, Fifth Affiliated Hospital of Xinjiang Medical University:
Gastrointestinal Microbiome
Additional relevant MeSH terms:
Layout table for MeSH terms
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Anti-Obesity Agents