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Hyperuricemia clinical trials

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NCT ID: NCT06463561 Not yet recruiting - Dyslipidemias Clinical Trials

CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea

CPAPLIP
Start date: June 20, 2024
Phase: Phase 4
Study type: Interventional

Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia. Objectives: Main objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA. Secondary objectives: - To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA. - To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA. - To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA. - To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA. - To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA. - To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA. - To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones. - To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid. Design Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment. Study population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications. Sample size: 110 patients in each treatment arm. Treatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms: 1. Conventional hygienic-dietary recommendations and promotion of daily physical activity. 2. Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP). Efficiency variables - Main variables: LDL-cholesterol and uric acid. - Total cholesterol, HDL-cholesterol and triglycerides. - Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein. - Systemic biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A/hypocretin 1 and ghrelin). - Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ. Safety variables - Clinical adverse event reporting. - CPAP compliance (average hours of use per day). - Epworth Sleepiness Questionnaire. - Development of cardiovascular events.

NCT ID: NCT06439602 Recruiting - Gout Clinical Trials

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients

Start date: June 2024
Phase: Phase 3
Study type: Interventional

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

NCT ID: NCT06420401 Recruiting - Clinical trials for Subjects With Hyperuricemia

Prebiotics and the Management of Hyperuricemia

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel theraputic target for hyperuricemia. Both annimal studies and pilot human trials have demonstrated that administration of prebiotics help delay the progression of hyperuricemia throuh several mechanisms. This trial aims to examine its protective effects and potential mechanisms in clinical trials.

NCT ID: NCT06414837 Not yet recruiting - Clinical trials for Gout With Hyperuricemia in Adults

Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.

NCT ID: NCT06315569 Recruiting - Hyperuricemia Clinical Trials

The Effect of Exercise at Different Time Intervals on Hyperuricemia

Start date: May 24, 2024
Phase: N/A
Study type: Interventional

The study aim is to explore the correlation between exercise and hyperuricemia, find out the metabolic rule of uric acid after exercise, and provide scientific evidence and clinical guidance for how to exercise scientifically and reasonably in patients with hyperuricemia. This trial is a multicenter, prospective, randomized controlled clinical trial with 100 participants. Inclusion criteria: 1. Patients with hyperuricemia (fasting uric acid > 420μmol/L twice on different days); 2. Men aged between 18 and 35; 3. Able to complete baseline fitness test (3000m run time less than 14 minutes); 4. Fully informed consent, signed informed consent exclusion criteria: 1. Patients with heart, liver and kidney insufficiency. 2. Subjects suffering from severe or uncontrollable organic diseases may interfere with study parameters such as hypertension, hyperlipidemia, hyperglycemia, tumor, cardiovascular, lung and digestive diseases. 3. Patients with secondary hyperuricemia caused by other diseases. 4. Take any drugs that may cause uric acid changes in the past 4 weeks. 5. Those who have related motor function or other factors are easy to cause discomfort after exercise. 6. Those who have mental illness or communicate do not cooperate during the test. A total of 100 participants participated in the study(Group A n = 50 ; Group B n = 50 ). The subjects are divided into two groups, designated as A and B. Following the completion of the grouping, all subjects complete the initial 3000 m run. The second 3000 m run is performed on the seventh day following the initial run. The interval between the third run and the second run in Group A is 24 hours, while the interval in Group B is 48 hours. During the 48-hour observation period after each exercise, the changes of uric acid after exercise were explored. To provide scientific evidence and clinical guidance for patients with hyperuricemia how to exercise scientifically and rationally. Patients must meet all inclusion and exclusion criteria to be eligible to participate in the study. After determining patients' eligibility for the study, the researcher should fully explain the nature, purpose, risks and benefits of the study to the subjects before the study, and assure the patients that they have the right to withdraw at any time after agreeing to participate in the study, and the subjects should sign a written informed consent after fully considering and agreeing to participate in the study. The process of obtaining informed consent should be correctly recorded in all case report forms in this study. Baseline data such as blood uric acid, blood biochemistry, blood routine, urine routine, uric acid, and demographic characteristics were collected after the patients were enrolled. The patients were randomly divided into two groups: Group A and Group B. Within 48 hours after each 3000m exercise, the subjects' blood uric acid was detected after exercise 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, 36 hours, 48 hours. From January 2024 to February 2024, we plan to draft clinical study protocols, investigator manuals, case reports, informed consent forms and other documents, and submit them to the Ethics Committee of the research sponsor for review and approval; February 2024 - March 2024: Complete the training of all researchers and officially start the research; March 2024 - August 2024: Participants were enrolled for the experiment; August 2024 - November 2024: collate and collect data, conduct statistical analysis, and confirm research results

NCT ID: NCT06315543 Recruiting - Hyperuricemia Clinical Trials

Effect of Increased Daily Water Intake in Patients With Hyperuricemia

Start date: May 23, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the clinical effect of reducing uric acid by drinking water, and provide scientific evidence and clinical guidance for reducing uric acid by drinking water. The study design was a multicenter, prospective, randomized controlled clinical trial with a total of 88 participants (Group A n=44; Group B n=44). 1. Inclusion criteria: patients with hyperuricemia (fasting uric acid between 420-540μmol/L twice on different days and no drug treatment); Aged 18-65 years; Less than 1500mL of daily water intake recommended by the minimum dietary guidelines (assessed by dietary review combined with water diaries); Fully informed consent. Sign informed consent. 2. Exclusion criteria: Patients with heart, liver and kidney insufficiency; Patients with severe or uncontrollable organic diseases that may interfere with the study parameters (such as tumors, cardiovascular, pulmonary and digestive diseases, hypertension, hyperlipidemia, hyperglycemia, thyroid diseases) or psychiatric disorders that affect eating behavior (such as primary polydipsia, bulimia nervosa, Psychiatric disorders, etc.); Patients with secondary hyperuricemia caused by other diseases; Patients who have taken any drug that causes changes in uric acid within five half-lives of the drug; Receiving treatment that can change the assessment of hydration status in the study (taking diuretics, glucocorticoids, or treatments that interfere with metabolism); Those who have gastrointestinal discomfort or a history of gastrointestinal surgery after drinking water, and other patients who are not suitable to drink too much water. A total of 88 subjects were included according to the exclusion criteria. The subjects were divided into two groups: Group A adequate drinking water intervention group (drinking an additional 1650mL of water per day (3 bottles of 550mL bottled water) on the basis of the original drinking water volume); Group B constant drinking water observation group (maintaining the original drinking water volume). During the 2-week observation period, the effects of sufficient drinking water on blood uric acid, urine osmotic pressure and other indicators were evaluated, and the effectiveness of sufficient drinking water in reducing blood uric acid was determined, and the applicable population was explored. Observation items and detection time: 1. During the screening period, the following data were collected: age, nationality, place of residence, education, occupation, height, weight, waist circumference, disease history, drug use history, drinking, smoking, normal water intake, urine volume, urine color and uric acid value. 2. Pre-test data: drinking water, urination, diet, psychological investigation, blood uric acid, blood biochemistry, routine blood routine, urine routine, uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure, heart rate, frequency of gout attack, whether to take uric-lowering drugs, whether to take other drugs that affect uric acid. 3. After the test: Fasting blood uric acid was monitored on the 2nd, 4th, 6th, 8th, 10th and 14th day respectively; Urge patients to record water diary and urination diary every day. At the end of the experiment, blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure and heart rate were tested again. Safety assessment indicators: edema, gastrointestinal discomfort, electrolytes, blood pressure, heart rate.

NCT ID: NCT06310967 Not yet recruiting - Hyperuricemia Clinical Trials

A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease

Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II clinical study to evaluate the safety, tolerability, PK, and efficacy of IG3018 tablet in hyperuricemia (HUA) subjects with or without CKD.

NCT ID: NCT06196580 Completed - Clinical trials for Gout and Hyperuricemia

PK Effects of SHR4640 on Repaglinide and Midazolam, and the Impact of SHR4640 on QT Interval

Start date: January 4, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the PK effects of SHR4640 tablets on repaglinide and midazolam, as well as the effects of SHR4640 tablets on the QT interval in healthy subjects.

NCT ID: NCT06189404 Completed - Gout Clinical Trials

Effect of Tigulixostat on the Pharmacokinetics of Theophylline

Start date: October 31, 2023
Phase: Phase 1
Study type: Interventional

A phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers.

NCT ID: NCT06168929 Completed - Hyperuricemia Clinical Trials

Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects

Start date: December 13, 2023
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.