Identification and Characterization of NAFLD in Turkey

NCT05194553 | Completed

• 1 other identifier: UMPAX-21-1
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) 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). NAFLD 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% non-alcoholic steatohepatitis (NASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with NAFLD 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 NAFLD patients are currently not detected due to the lack of non-invasive methods to diagnose NAFLD. To date, the prevalance of NAFLD in Turkey among subjects at risk, and its relation to common comorbidities such as obesity, T2DM and CVD is not clear. Therefore, identification of NAFLD 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 NAFLD among risk groups. Also, the risk factors related to NAFLD 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 NAFLD.

Conditions

Non-Alcoholic Fatty Liver Disease; Liver Diseases; Fatty Liver; Metabolic Syndrome; Overweight and Obesity

Keywords

NAFLD; fatty liver; NASH; non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

• prevalence of NAFLD in risk groups in Turkey

  1 year

Secondary Outcomes (10)

• NAFLD's relation to risk factor: overweight

  1 year

• NAFLD's relation to risk factor: obesity

  1 year

• NAFLD's relation to risk factor: IR

  1 year

• NAFLD's relation to risk factor: T2DM

  1 year

• NAFLD's relation to risk factor: HT

  1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

500 male and female participants aged between 18-80, who can sign the informed consent and are eligible to participate.

You may qualify if:

• Able to understand and sign the informed consent
• Able to speak Turkish
• Between 18-80 years
• BMI \>25 kg/m²
• Having one of the following conditions: 1)Insulin resistance 2)Impaired glucose tolerence 3)type 2 diabetes mellitus, 4)hypertension 5)dyslipidemia 6)cardiovascular diseases (atherosclerosis, angina pectoris, ischaemic heart condition, cerebrovascular condition)

You may not qualify if:

• 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)
• Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
• Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART), lean steatosis, Celiac disease, environmental toxicity
• Pregnancy and breastfeeding.
• A history of bariatric surgery.
• Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
• Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.
• Individuals about to undergo a surgery or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time (e.g., after 3 months are myocardial infarction patients are eligible for participation).

Sponsors & Collaborators

• Maastricht University: lead
• Pax Clinic: collaborator

Study Sites (1)

Pax Clinic

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Fatty Liver; Metabolic Syndrome; Overweight; Obesity

Condition Hierarchy (Ancestors)

Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: February 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 15, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

TU (1)