Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.

NCT03884127 | Unknown DMC FDA Drug

• 1 other identifier: FifthXinjiang
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperlipidemia

Keywords

orlistat; Ezetimibe; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (3)

• blood lipid

  Triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol

  enroll(0 month)，finish(3 month)

• bile acid

  total bile acid

  enroll(0 month)，finish(3 month)

• Gastrointestinal flora

  Firmicutes, bacteroides

  enroll(0 month)，finish(3 month)

Study Arms (1)

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.

Drug: Ezetimibe 10mg; Drug: Orlistat 120 MG

Interventions

Ezetimibe 10mg DRUG

On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks

Also known as: lifestyle intervention

hyperlipidaemia

Orlistat 120 MG DRUG

On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks

Also known as: lifestyle intervention

hyperlipidaemia

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Fifth Affiliated Hospital of Xinjiang Medical University: lead
• West China Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Fecal bacteria DNA

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Ezetimibe; Orlistat

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lactones; Organic Chemicals

Study Officials

• haoming tian, master

  West China Hospital

  STUDY CHAIR

Central Study Contacts

jin jin, master

CONTACT

+8613319809893; jinjin@xjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: In excel form,include Baseline data, post-intervention outcomes