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Fatty Liver clinical trials

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NCT ID: NCT06449833 Recruiting - Clinical trials for Type2 Diabetes Mellitus

Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD

HHTN
Start date: June 2024
Phase: Phase 4
Study type: Interventional

This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.

NCT ID: NCT06448195 Recruiting - Clinical trials for Growth Hormone Treatment

Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

Growth Hormone (GH) is essential for maintaining fat, muscle, bone, and energy balance. Adult Growth Hormone Deficiency (GHD) affects about 0.3% of adults. GHD, common post-pituitary tumor surgery or radiotherapy, disrupts lipid metabolism, increasing triglycerides and low-density lipoprotein cholesterol while decreasing high-density lipoprotein cholesterol. This is especially severe in GH adenoma patients, whose lipid metabolism issues worsen post-surgery, increasing the risk of atherosclerosis. Fat accumulates in the liver first, making liver fat content a key early indicator of metabolic disorders, which can lead to diabetes and atherosclerosis. Early intervention is crucial as liver fat deposition in Nonalcoholic Fatty Liver Disease (NAFLD) is reversible. Recombinant human growth hormone can treat GHD-related lipid metabolism disorders, but research on its effects on liver fat in post-surgery GH adenoma patients is limited. The investigators plan to treat these patients with 1 mg/week of recombinant human growth hormone for 24 weeks, aiming to normalize insulin-like growth factor-1 levels. Liver fat content changes will be measured using proton magnetic resonance spectroscopy (1H MRS) and Fibroscan. Changes in weight, BMI, waist circumference, fasting blood glucose, blood lipids, and other metabolic factors will also be evaluated to assess treatment efficacy and safety. Zhongshan Hospital, affiliated with Fudan University, performs over 300 pituitary tumor surgeries annually, including 100 GH adenoma cases. The hospital has extensive experience and can enroll 40 patients. The Endocrinology Department excels in evaluating lipid metabolism disorders in NAFLD using non-invasive methods. As a major hospital in Shanghai, it has ample patients to meet study requirements. Detailed exit criteria and rescue plans have been established to address potential adverse events during the study.

NCT ID: NCT06445361 Recruiting - Type 1 Diabetes Clinical Trials

Prevalence of NAFLD in T1DM Patients

PAD1ZOL
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

To determine the prevalence of NAFLD in T1DM patients.

NCT ID: NCT06419374 Recruiting - Clinical trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Start date: May 24, 2024
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

NCT ID: NCT06403332 Recruiting - Clinical trials for Alcohol Use Disorder

Study of the Drivers of Late Diagnosis of Alcohol Related Diseases, Alone or in Combination With Metabolic Dysfunconal Associated Fatty Liver Disease, Implementation and Evaluation of Itnerventions to Reduce Its Burden.

StopALD
Start date: February 2, 2023
Phase: N/A
Study type: Interventional

Excessive alcohol use is a leading risk factor for preventable disability and death. Alcohol-related liver disease (ALD) is one of the better-known detrimental consequences of alcohol abuse and is the main cause of disability-adjusted life years (DALYs) in European adults. ALD is the main cause of cirrhosis globally and is responsible for 60% of cirrhosis in Europe and North America. Importantly, another etiology of liver disease is on the rise due to the epidemics of obesity and diabetes mellitus in Western countries, i.e., metabolic dysfunction associated fatty liver disease (MAFLD). ALD and MAFLD are largely shaped by social determinants of health (SDH) and lead to mounting health inequalities. Moreover, ALD is subject to strong stigmatization, particularly amongst women, which often leads to lack of inquiry by health professionals. Alone or in combination (MAFLD-OH), both diseases represent a challenge for epidemiologists, clinicians and policy makers in charge of health systems' organization. One of the hurdles to reduce the burden of ALD is the lack of early detection of asymptomatic liver disease among patients with alcohol use disorder (AUD) and heavy drinkers. The only measure that has been proven effective in any phase of the disease is to either stop, compensate, or reverse the liver disease progression, is alcohol abstinence. We hypothesize that establishing effective screening programs to identify patients with ALD and related disorders, coupled with effective treatment will lead to more positive outcomes in prognosis. The central aim of the StopALD Project is to identify patients with advanced ALD during the asymptomatic phases of the disease, as well as identifying the factors related with the lack of early detection to better implement interventions so to tackle both the lack of early detection of ALD and heavy drinking patterns among young people before ALD occurs.

NCT ID: NCT06402084 Recruiting - Clinical trials for The Relationship Between Fatty Liver and Breast Cancer

The Relationship Between Fatty Liver and Breast Cancer

Start date: May 2, 2024
Phase:
Study type: Observational

clinicopathological result of a common is (NAFLD) alcoholic fatty liver disease-nNo 30% of -NAFLD affects 20% .not caused by alcohol intake is chronic liver disease thatsuch as conditions spectrum of population and can be characterized by wide general et Chalasani( steatosis by isolated intracellular fat deposition marked noninflammatory .al., 2012) homeostasis and egulation of hepatic cholesterol NAFLD occurs due to the dysr . NAFLD is liver in triglycerides and free cholesterol, free fatty acids, accumulation ofabdominal and with insulin resistance, diabetes mellitus, metabolic syndrome associatedimplicated in the be can NAFLD that suggested reports the arge number ofL .obesity kidney diseases as well as cancersf cardiovascular, pulmonary, and pathology o .2015) et al., (Arguello their course of the Patients with breast cancer commonly develop NAFLD during .45.2%-2.3% approximately cancer is disease. The incidence of NAFLD in breast by influenced metabolic profile and is patient's NAFLD seems to be associated with cardiovascular and resistance insulin causingand treatment, breast cancer complications (Lee et al., 2017). modulators term estrogen inhibition with selective estrogen receptors-Long liver with tamoxifen fatty incidence of The s been reported to cause NAFLD.ha (SERMs)of NAFLD development in impact heT . use an that for aromatase inhibitoruse is higher th et al., (Yang breast cancer patients after hormonal treatment has not yet been elucidated .)6201 main and is aworldwide most common cancer in womenBreast cancer is the decreasing with has been cancer breast from ityortalM .women in death cancer of causeIt is well known time given the advances in screening strategies and adjuvant treatments. incidence of breast cancer is correlated with age and other risk factors such asthat the mutation, family history of )BRCA2( breast cancer gene2 or )BRCA1(gene1breast cancer al.,et Berry( and hormonal factors chest the to breast cancer, therapeutic radiation5).200 Breast cancer is divided according to the hormone receptors into either hormone receptor-positive tumors which are estrogen receptor-positive (ER-positive) and progesterone receptor-positive (PR-positive). These tumors express hormone receptors. This means they have a lot of hormone receptors. Hormone receptor-negative tumors are estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative). These tumors donot express hormone receptors. This means they have few or no hormone receptors. About 70% to 80% of newly diagnosed breast cancers are hormone receptor- .al., 2017) (Wang et positive

NCT ID: NCT06400771 Recruiting - Clinical trials for Liver Transplant; Complications

Safety of DNP007 in Healthy Subjects

Start date: June 10, 2024
Phase: Phase 1
Study type: Interventional

This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number.

NCT ID: NCT06392828 Recruiting - Clinical trials for Cardiovascular Diseases

EndoNAFLD: Relationship Between Fatty Liver Disease and Cardiovascular Diseases

Endo-NAFLD
Start date: April 15, 2024
Phase:
Study type: Observational

Management of risk factors is the primary approach to prevent cardiovascular disease (CVD). In this regard the accurate scoring of disease risk is fundamental. Non-alcoholic fatty liver disease (NAFLD) has emerged recently as a potential mediator of CVD onset and progression. The hypothesis is that NAFLD can be a predictive CVD risk factor, independent of other classical and well-known risk factors. Preliminary epidemiological studies suggested that the fat infiltration in the liver mirrored the cardiometabolic status of the patient. But recent studies postulate that NAFLD could be a potential independent predictor of vascular injury. The mechanisms that link liver function and endothelial damage include modulation of adipose tissue function, lipid metabolism regulation or glycemic homeostasis, among others. But new mechanisms that could link NAFLD and ECV are emerging. The synthesis of ketone bodies in the liver is closely related to the cardiovascular system function. Ketone bodies can provide up to 50% of energy required by specific tissues. Plasma concentration of β-hydroxybutyrate is a biomarker of NAFLD. Plasma β-hydroxybutyrate and acetoacetate levels are also inversely associated with endothelial injury. Other biomarkers on endothelial damage like von Willebrand factor, ICAM, VCAM or coagulation factors (Factor VIII) can be used to stratify patients according to the risk of CVD. The improvement in the sensitivity, specificity and accuracy of scores such as FLI, HIS and FIB-4 and non-invasive techniques such as elastography allow the study of the relationship between liver disease and other comorbidities. The aim is to evaluate the potential of NAFLD to stratify patients according to the risk of CVD and to investigate the molecular mechanisms linking NAFLD and CVD.

NCT ID: NCT06386094 Recruiting - Cardiac Disease Clinical Trials

Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease

Start date: July 15, 2023
Phase:
Study type: Observational

Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.

NCT ID: NCT06368882 Recruiting - Chronic Hepatitis b Clinical Trials

Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease(OCEAN PROJECT)

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

This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease. A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group(500 patients receiving NAs monotherapy) according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly. The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up. The security assessment includes adverse events, vital signs, and imaging.