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NCT Number: NCT04999124

Characteristics of NAFLD Among Type 2 Diabetes Patients

Type 2 diabetes patients have a high risk of developing NAFLD. This was confirmed during previous research, a high prevalence of NAFLD among type 2 diabetes mellitus patients was found. The investigators want to determine the characteristics of this population.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type2 Diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years,
  • having type 2 diabetes,
  • able to understand Dutch,
  • able to understand the informed consent

Exclusion criteria

  • excessive alcohol abuse,
  • other liver disease,
  • secondary causes of steatosis

Treatment and study plan

Screening and studying characteristics

Other

Type 2 diabetes patients have a high risk of developing NAFLD. This was confirmed during previous research, a high prevalence of NAFLD among type 2 diabetes mellitus patients was found. Now we want to determine the characteristics of this population.

Primary outcomes

  1. VCTEM (KPa) measure

    Time frame: up to year four

    The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined.

  2. CAPTM (dB/m) measure

    Time frame: up to year four

    The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.

  3. Liver Ultrasound

    Time frame: up to year four

    Out of the EPF (Electronic Patient file) the results of a possible earlier ultrasound are noted in the CRF. The results are noted as 'liver steatosis found' with yes/no answer and the year in which this ultrasound was performed.

  4. Liver biopsy

    Time frame: up to year four

    Out of the EPF the results of a possible earlier ultrasound or liver biopsy are noted in the CRF. The results are noted as previous NAFLD diagnosis with yes/no answer and if confirmed by liver biopsy results. Next the NAS CRN (histological) score is noted.The score ranges from 0-8 and is composed of the unweighted sum of steatosis, ballooning, and lobular inflammation. A score between 0-2 corresponds to no NASH, 3-4 is borderline NASH, and definite NASH has a score between 5 and 8.

  5. Aspartate transaminase (AST)

    Time frame: up to year four

    Out of the EPF the blood parameter AST (U/L) will be collected

  6. Alanine transaminase (ALT)

    Time frame: up to year four

    Out of the EPF the blood parameter ALT (U/L) will be collected.

  7. Gamma glutamyltransferase (GGT)

    Time frame: up to year four

    Out of the EPF the blood parameter GGT (U/L) will be collected.

  8. Lactate dehydrogenase (LDH)

    Time frame: up to year four

    Out of the EPF the blood parameter LDH (U/L) will be collected.

  9. total protein

    Time frame: up to year four

    Out of the EPF the blood parameter total protein (g/L) will be collected.

  10. Albumin

    Time frame: up to year four

    Out of the EPF the blood parameter albumin (mg/dL) will be collected.

  11. Ferritin

    Time frame: up to year four

    Out of the EPF the blood parameter ferritin (µg/L) will be collected.

  12. bilirubin total

    Time frame: up to year four

    Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected.

  13. Exclusion of other liver diseases

    Time frame: up to year four

    hepatitis B, hepatitis C, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson disease and alpha 1 antitrypsin deficiency. NAFLD is a disease of exclusion and therefore the abovementioned parameters are determined out of the EPF.

  14. Weight

    Time frame: up to year four

    The weight (kg)

  15. Height

    Time frame: up to year four

    The height (m)

  16. BMI (Body Mass Index)

    Time frame: up to year four

    The weight (kg) and height (m) will be determined and from this the BMI (kg/m²) will be calculated.

  17. waist circumference

    Time frame: up to year four

    The waist circumference will be measured and noted in cm.

  18. Wellbeing - BAECKE

    Time frame: up to year four

    This questionnaire will be used to estimate the level of physical activity. It exists out of 16 questions about work, sports and leisure time. A higher score means that the person is more active at work, does more sport and has a more active leisure time. Minimum value is 3 and maximum value is 15.

  19. Wellbeing - GAD-7

    Time frame: up to year four

    General Anxiety Disorder (GAD-7) questionnaire will be used to determine the presence of possible clinically significant anxiety disorder.A higher scores indicates having anxiety. Minimum score is 0 and maximum score is 21.

  20. Wellbeing - PHQ-9

    Time frame: up to year four

    Patient Health Questionnaire-9 (PHQ-9) will be used to quantify depression symptoms and monitor severity. . Minimum score is 0 and maximum score is 27. A higher score indicates having a depression.

  21. Wellbeing - WPAI-SHP

    Time frame: up to year four

    Workers Productivity and Activity Impairment (WPAI-SHP) questionnaire. By means of 6 questions about work productivity and activity it can be determined if there is absence, productivity loss or a decrease in activities at work. By means of 6 questions about work productivity and activity it can be determined if there is absence, productivity loss or a decrease in activities at work. The score is expressed in percentages (0-100). A higher percentage indicates a higher absence from work and a lower productivity.

  22. Wellbeing - SF-36

    Time frame: up to year four

    Short Form Health Survey-36 will be used to determine the health related quality of life based on 6 different topics: physical functioning, social functioning, role restrictions, mental wellbeing, energy and pain. The score is expressed in percentages (0-100). A higher percentage indicates a better general wellbeing.

  23. Diagnosis Diabetes

    Time frame: up to year four

    The year of diagnosis is asked to the patient (yr).

  24. Diabetes complications

    Time frame: up to year four

    The complications (retinopathy, nephropathy and neuropathy) of diabetes are asked to the patient and gathered out of the EPF. Answer will be yes/no to each of the complications.

Secondary outcomes

  1. concomitant medication

    Time frame: up to year four

    The medication use will be noted in the CRF

  2. serum creatine

    Time frame: up to year four

    serum creatine (mg/dL)

  3. urine creatine

    Time frame: up to year four

    urine creatine (mg/dL)

  4. micro-albumin

    Time frame: up to year four

    micro-albumin (mg/dL)

  5. albumin/creatine ratio

    Time frame: up to year four

    albumin/creatine ratio (mg/g creat)

  6. estimated glomerular filtration rate

    Time frame: up to year four

    estimated glomerular filtration rate (ml/min/1,73m²).

  7. Triglycerides (mg/dL)

    Time frame: up to year four

    Triglycerides (mg/dL) in blood

  8. HDL (mg/dL)

    Time frame: up to year four

    HDL (mg/dL) in blood

  9. LDL cholesterol (mg/dL)

    Time frame: up to year four

    LDL cholesterol (mg/dL) in blood

  10. Total cholesterol (mg/dL).

    Time frame: up to year four

    Total cholesterol (mg/dL) in blood

  11. thrombocytes

    Time frame: up to year four

    thrombocytes (1000/µL) in blood

  12. fasting glucose (mg/dL)

    Time frame: up to year four

    fasting glucose (mg/dL) in blood

  13. partial alpha fetoprotein (AFP)

    Time frame: up to year four

    partial alpha fetoprotein (AFP) in blood

  14. haemoglobin A1c (%)

    Time frame: up to year four

    haemoglobin A1c (%) in blood

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

Study of the Characteristics of Non-Alcoholic Fatty Liver Disease (NAFLD) in Type 2 Diabetes Mellitus Patients Followed in a Hospital Environment in Flanders, Belgium

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 10, 2021
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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