NAFLD Primary Care
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Cardiovascular Diseases, Type2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FibroScan
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Able to understand and sign the informed consent
- Able to speak Dutch
- Between 18-80 years
- BMI >25 kg/m²
- Having one of the following conditions: 1)overweight, 2) obesity, 3) type 2 diabetes mellitus, 4) cardiovascular diseases (hypertension, atherosclerosis, angina pectoris, ischaemic heart condition, cerebrovascular condition)
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)
- 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).
Sites / Locations
- Maastricht UniversityRecruiting
Outcomes
Primary Outcome Measures
Prevalence of NAFLD in risk groups followed by the general practitioner
Secondary Outcome Measures
To study the risk factor overweight in the development of NAFLD
To see if there is an effect of having a BMI between 25 and 30 kg/m² in the development of NAFLD. The physiological parameter used will be BMI.
To study the risk factor obesity in the development of NAFLD
To see if there is an effect of having a BMI between 30-40 kg/m² on the development of NAFLD. The physiological parameter used will be BMI.
To study the risk factor metabolic syndrome in the development of NAFLD
To see if there is an effect of metabolic syndrome (defined by the criteria of the International Diabetes Federation) on the development of NAFLD.
To study the risk factor type 2 diabetes mellitus in the development of NAFLD
Type 2 diabetes mellitus will be assessed based on previous diagnosis and HbA1c levels.
To study the risk factor cardiovascular diseases in the development of NAFLD
Cardiovascular diseases will be assessed based on medical history found in the EPF.
To assess if the patient has a depression
Depression will be assessed using the patient-health questionnaire 9 (PHQ-9).
To assess if the patient has a anxiety issues
Anxiety will be assessed using the general anxiety disorder questionnaire (GAD-7)
To assess if the general wellbeing of the patient.
General wellbeing will be assessed using the short-health form-36 (SF-36).
To assess the physical state of the patient.
The physical state will be assessed using the BAECKE questionnaire.
To assess the work productivity and absenteism of the patient.
The work productivity will be assessed using the WPAI-SHP questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04918732
Brief Title
NAFLD Primary Care
Official Title
Identification and Characterization of Non-alcoholic Fatty Liver Disease in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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), cardiovascular diseases (CVD) and increased risk of cancer development. 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 non-alcoholic fatty liver (NAFL) 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 aspecific 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, there is a striking lack of awareness on all levels of NAFLD. Furthermore, little to know data are available concerning the quality of life of NAFLD patients. Additionally, the majority of NAFLD patients are currently not detected due to the lack of non-invasive methods to diagnose NAFLD. Most of these patients, as a first contact in the healthcare system, will be found in the outpatient clinic of the general practitioner (GP). To date, it is not clear what the burden is of NAFLD and related diseases in at risk subjects in primary care. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Cardiovascular Diseases, Type2 Diabetes, Metabolic Syndrome, Overweight and Obesity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1470 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
FibroScan
Intervention Description
The FibroScan device developed by Echosens (France) measures the liver stifness and steatosis based on a pulse of sound waves that goes through the liver.
Primary Outcome Measure Information:
Title
Prevalence of NAFLD in risk groups followed by the general practitioner
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To study the risk factor overweight in the development of NAFLD
Description
To see if there is an effect of having a BMI between 25 and 30 kg/m² in the development of NAFLD. The physiological parameter used will be BMI.
Time Frame
3 years
Title
To study the risk factor obesity in the development of NAFLD
Description
To see if there is an effect of having a BMI between 30-40 kg/m² on the development of NAFLD. The physiological parameter used will be BMI.
Time Frame
3 years
Title
To study the risk factor metabolic syndrome in the development of NAFLD
Description
To see if there is an effect of metabolic syndrome (defined by the criteria of the International Diabetes Federation) on the development of NAFLD.
Time Frame
3 years
Title
To study the risk factor type 2 diabetes mellitus in the development of NAFLD
Description
Type 2 diabetes mellitus will be assessed based on previous diagnosis and HbA1c levels.
Time Frame
3 years
Title
To study the risk factor cardiovascular diseases in the development of NAFLD
Description
Cardiovascular diseases will be assessed based on medical history found in the EPF.
Time Frame
3 years
Title
To assess if the patient has a depression
Description
Depression will be assessed using the patient-health questionnaire 9 (PHQ-9).
Time Frame
3 years
Title
To assess if the patient has a anxiety issues
Description
Anxiety will be assessed using the general anxiety disorder questionnaire (GAD-7)
Time Frame
3 years
Title
To assess if the general wellbeing of the patient.
Description
General wellbeing will be assessed using the short-health form-36 (SF-36).
Time Frame
3 years
Title
To assess the physical state of the patient.
Description
The physical state will be assessed using the BAECKE questionnaire.
Time Frame
3 years
Title
To assess the work productivity and absenteism of the patient.
Description
The work productivity will be assessed using the WPAI-SHP questionnaire.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand and sign the informed consent
Able to speak Dutch
Between 18-80 years
BMI >25 kg/m²
Having one of the following conditions: 1)overweight, 2) obesity, 3) type 2 diabetes mellitus, 4) cardiovascular diseases (hypertension, atherosclerosis, angina pectoris, ischaemic heart condition, cerebrovascular condition)
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)
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).
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ger Koek, MD, PhD
Phone
0031-43-3875021
Email
nafldstudie@gmail.com
12. IPD Sharing Statement
Learn more about this trial
NAFLD Primary Care
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