Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease (NAFLD Cohort Study)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this observational study is to establish a unified cohort for retrospective and prospective high quality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria. This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be ≥ 18 years of age at the time of signing the informed consent

• Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits

• To have a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino and collaborating/referring clinicians based on:

‣ Liver biopsy with a histological evidence of NAFLD/NASH/MAFLD OR

⁃ Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR

⁃ Diagnosis of metabolic syndrome and liver fibrosis or cirrhosis without an alternative diagnosis; metabolic syndrome fulfilling one or more of the below mentioned conditions:

• Abdominal obesity: a waist circumference of more than 35 inches (\>89cm) for women and more than 40 inches (\>102 cm) for men;

∙ High blood pressure of 130/80 mm Hg or higher. Normal blood pressure is defined as less than 130 mm Hg for systolic pressure, and less than 80 mm Hg for diastolic pressure

∙ Impaired fasting blood glucose. This means a level equal to or greater than 100 mg/dL (\>5.6 mmol/L)

∙ High triglyceride levels of more than 150 mg/dL (\> 1.7mmol/L).

∙ Low HDL (good) cholesterol: less than 40 mg/dL (\< 1.04 mmol/L) for men and less than 50 mg/dL (\< 1.29 mmol/L) for women

• alcohol consumption less than 21 (males) or 14 (women) units per week in the 6 months before the enrolment and no history of excessive alcohol consumption in the 5 years before enrolment. One unit is 12g (grams) of pure alcohol; 10-12 grams of pure alcohol are contained in a 280-330 ml of beer, 150-180 ml of champagne, 30-40 ml of whisky or high-strength spirit, 60-80 ml of liqueur, and 100-120 ml of red wine

Locations
Other Locations
Switzerland
Fondazione Epatocentro Ticino
RECRUITING
Lugano
Contact Information
Primary
Andreas Cerny, Prof. Dr. med
andreas.cerny@hin.ch
0041919106570
Backup
Maurizia Bissig
maurizia.bissig@hin.ch
Time Frame
Start Date: 2023-07-19
Estimated Completion Date: 2030-12
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Fondazione Epatocentro Ticino

This content was sourced from clinicaltrials.gov