Role of De Novo Lipogenesis in Nonalcoholic Fatty Liver Disease Severity
This observational study aims to understand the role of de novo lipogenesis (DNL) in the severity of nonalcoholic fatty liver disease, by directly measuring DNL in liver biopsies.
Data Collection
Collected from today forward - ProspectiveBody Weight+10
+ Digestive System Diseases
+ Fatty Liver
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 1, 2019
Actual date on which the first participant was enrolled.Nonalcoholic fatty liver disease (NAFLD) is a common condition where excess fat builds up in the liver. This study focuses on understanding how NAFLD progresses to a more severe state known as nonalcoholic steatohepatitis (NASH). The research team is particularly interested in a process called de novo lipogenesis (DNL), which is the liver's production of fats from carbohydrates. They believe that increased DNL might play a role in worsening NAFLD. The study aims to explore this by examining liver tissue from individuals with NAFLD, as understanding this process could potentially lead to improved treatments and care for those affected by this disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.49 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 22 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion and exclusion criteria are similar to the criteria set by a larger project (NCT03151798). Inclusion criteria: * Men and women (pre and post-menopausal) * Overweight/obese with BMI ≥ 25.9 or ≤ 50.0 kg/m2 * Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL or 2h glucose 140-200 mg/dL) or diabetes type II * 22-65 years of age * use of tobacco products or no use of these products * Sedentary, ≤ 60 minutes per week of structured physical activity Exclusion criteria: • The following conditions exclude subjects for this project because bariatric surgery would not be performed in these populations. Individuals with acute disease or advanced cardiac, liver, or renal disease, excessive alcohol use, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy \< 1 year. Women pregnant or trying to become pregnant.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location