CompletedNot Applicable

Identification and Characterization of At-risk MASLD in Turkish Adults

Turkey (Türkiye)459 participantsStarted 2023-01-01

Plain-language summary

MASLD is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). MASLD is defined by a hepatic fat accumulation of more than 5% in the absence of classical causes of steatogenesis (e.g. alcohol and steatogenic drugs). It represents a broad spectrum of clinical entities from steatosis to advanced liver disease with hepatic failure. Most of the patients have simple steatosis, however in about 15-30% steatohepatitis (MASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with MASLD have no or few, mainly specific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality. Despite the clinical importance and the potential impact on healthcare resources, the majority of MASLD patients are currently not detected due to the lack of non-invasive methods to diagnose MASLD. To date, the prevalance of MASLD in Turkey among subjects at risk, and its relation to common comorbidities such as obesity, T2DM and CVD is not clear. Therefore, identification of MASLD patients in this cohort will give information on the prevalence in the group of uncomplicated overweight and obesity and those with concomitant cardiometabolic diseases. By early detecting these patients at risk to develop progressive liver diseases and extrahepatic manifestations, it will be possible to intervene and improve health. Within this context, this study aims to detect prevalence of MASLD among risk groups. Also, the risk factors related to MASLD etiology and progression, such as overweight, obesity, T2DM, CVD, diet and physical activity will be studied to have a better understanding of their presumed causal relationship with MASLD. This study is designed to study the prevalence of and risk factors associated with MASLD in adult populations at-risk of MASLD. Participants will undergo liver assessments via vibration controlled transient elastography. Lifestyle, demographic, and biochemical data will be collected.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: One of the following conditions: * BMI ≥ 25 kg/m2 OR WC\> 94 cm (M) 80 cm (F) * Fasting serum glucose ≥ 100 mg/dL OR 2-hour post-load glucose levels ≥140 mg/dL OR HbA1c ≥ 5.7% OR type 2 diabetes OR treatment for type 2 diabetes * Blood pressure ≥ 130/85 mmHg OR specific antihypertensive drug treatment * Plasma triglycerides ≥ 150 mg/dL OR lipid lowering treatment * Plasma HDL-cholesterol ≤40 mg/dL (Male) and ≤ 50 mg/dL (Female) OR lipid lowering treatment Exclusion Criteria: * Excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 glasses alcohol/day for women and \>3 glasses for men) * Hepatitis B virus, * Hepatitis C virus, * Autoimmune hepatitis, * Primary biliary cirrhosis, * Hemochromatosis, * Wilson's disease, * Alpha 1 antitrypsin deficiency * HCV Genotype 3, * Total parental nutrition, * Current use of hepatotoxic medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART), * Celiac disease, * Pregnancy and breastfeeding * A history of bariatric surgery * Current diagnosis of liver cirrhosis and/or hepatocellular carcinoma. * Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Timeframe: baseline

Association Between Lifestyle Factors and Hepatic Steatosis

Timeframe: Baseline

Association of Circulating Biomarkers With MASLD

Timeframe: baseline

Trial details

NCT IDNCT07548970

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) trials