NCT03884127

Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.

Analysis of Changes in Intestinal Flora of Hyperlipidemia by Ezetimibe and Orlistat.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 58 (estimated)
• Sponsor: Fifth Affiliated Hospital of Xinjiang Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Ezetimibe 10mg	On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-08-30
• Completion: 2019-09-30
• First posted: 2019-03-21
• Last updated: 2019-03-21

Regulatory

• FDA-regulated drug study