Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.

• ClinicalTrials.gov Identifier: NCT03884127
• Recruitment Status: Unknown
• First Posted: March 21, 2019
• Last Update Posted: March 21, 2019
• Sponsor: Fifth Affiliated Hospital of Xinjiang Medical University
• Collaborator: West China Hospital
• Information provided by (Responsible Party): Jin jin, Fifth Affiliated Hospital of Xinjiang Medical University

Tracking Information

• First Submitted Date: March 19, 2019
• First Posted Date: March 21, 2019
• Last Update Posted Date: March 21, 2019
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: August 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 19, 2019)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.
• Official Title: Analysis of Changes in Intestinal Flora of Hyperlipidemia by Ezetimibe and Orlistat.
• 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.

Detailed Description

1. 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.
2. 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.
3. 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: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Fecal bacteria DNA

• 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
• Condition: Hyperlipidemia

Intervention

• 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

Study Groups/Cohorts

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.

Interventions:

• Drug: Ezetimibe 10mg
• Drug: Orlistat 120 MG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 19, 2019): 58
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2019
• Estimated Primary Completion Date: August 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03884127
• Other Study ID Numbers: FifthXinjiang
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: After the study is completed, the results will be uploaded
• Supporting Materials: Study Protocol
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: starting 6 months after publication
• Access Criteria: In excel form,include Baseline data, post-intervention outcomes

• Responsible Party: Jin jin, Fifth Affiliated Hospital of Xinjiang Medical University
• Study Sponsor: Fifth Affiliated Hospital of Xinjiang Medical University
• Collaborators: West China Hospital

Investigators

• Study Chair: haoming tian, master; West China Hospital

• PRS Account: Fifth Affiliated Hospital of Xinjiang Medical University
• Verification Date: February 2019