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出境医 / 临床实验 / NAFLD Primary Care

NAFLD Primary Care

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Cardiovascular Diseases Type2 Diabetes Metabolic Syndrome Overweight and Obesity Diagnostic Test: FibroScan Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1470 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification and Characterization of Non-alcoholic Fatty Liver Disease in Primary Care
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Prevalence of NAFLD in risk groups followed by the general practitioner [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To study the risk factor overweight in the development of NAFLD [ Time Frame: 3 years ]
    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.

  2. To study the risk factor obesity in the development of NAFLD [ Time Frame: 3 years ]
    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.

  3. To study the risk factor metabolic syndrome in the development of NAFLD [ Time Frame: 3 years ]
    To see if there is an effect of metabolic syndrome (defined by the criteria of the International Diabetes Federation) on the development of NAFLD.

  4. To study the risk factor type 2 diabetes mellitus in the development of NAFLD [ Time Frame: 3 years ]
    Type 2 diabetes mellitus will be assessed based on previous diagnosis and HbA1c levels.

  5. To study the risk factor cardiovascular diseases in the development of NAFLD [ Time Frame: 3 years ]
    Cardiovascular diseases will be assessed based on medical history found in the EPF.

  6. To assess if the patient has a depression [ Time Frame: 3 years ]
    Depression will be assessed using the patient-health questionnaire 9 (PHQ-9).

  7. To assess if the patient has a anxiety issues [ Time Frame: 3 years ]
    Anxiety will be assessed using the general anxiety disorder questionnaire (GAD-7)

  8. To assess if the general wellbeing of the patient. [ Time Frame: 3 years ]
    General wellbeing will be assessed using the short-health form-36 (SF-36).

  9. To assess the physical state of the patient. [ Time Frame: 3 years ]
    The physical state will be assessed using the BAECKE questionnaire.

  10. To assess the work productivity and absenteism of the patient. [ Time Frame: 3 years ]
    The work productivity will be assessed using the WPAI-SHP questionnaire.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE May 19, 2021
First Posted Date  ICMJE June 9, 2021
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE May 5, 2021
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2021) 		Prevalence of NAFLD in risk groups followed by the general practitioner [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
  • To study the risk factor overweight in the development of NAFLD [ Time Frame: 3 years ]
    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 [ Time Frame: 3 years ]
    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 [ Time Frame: 3 years ]
    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 [ Time Frame: 3 years ]
    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 [ Time Frame: 3 years ]
    Cardiovascular diseases will be assessed based on medical history found in the EPF.
  • To assess if the patient has a depression [ Time Frame: 3 years ]
    Depression will be assessed using the patient-health questionnaire 9 (PHQ-9).
  • To assess if the patient has a anxiety issues [ Time Frame: 3 years ]
    Anxiety will be assessed using the general anxiety disorder questionnaire (GAD-7)
  • To assess if the general wellbeing of the patient. [ Time Frame: 3 years ]
    General wellbeing will be assessed using the short-health form-36 (SF-36).
  • To assess the physical state of the patient. [ Time Frame: 3 years ]
    The physical state will be assessed using the BAECKE questionnaire.
  • To assess the work productivity and absenteism of the patient. [ Time Frame: 3 years ]
    The work productivity will be assessed using the WPAI-SHP questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NAFLD Primary Care
Official Title  ICMJE Identification and Characterization of Non-alcoholic Fatty Liver Disease in Primary Care
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Non-Alcoholic Fatty Liver Disease
  • Cardiovascular Diseases
  • Type2 Diabetes
  • Metabolic Syndrome
  • Overweight and Obesity
Intervention  ICMJE Diagnostic Test: FibroScan
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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2021) 		1470
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04918732
Other Study ID Numbers  ICMJE METC20-051
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University
Study Sponsor  ICMJE Maastricht University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maastricht University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP