Non-Alcoholic Fatty Liver DiseaseNCT04999124
Characteristics of NAFLD Among Type 2 Diabetes Patients
A study testing Screening and studying characteristics in people with Non-Alcoholic Fatty Liver Disease and Type2 Diabetes, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Type2 Diabetes
- What is being tested?
- Screening and studying characteristics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,762 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years,
- having type 2 diabetes,
- able to understand Dutch,
- able to understand the informed consent
Who cannot join
- excessive alcohol abuse,
- other liver disease,
- secondary causes of steatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Type2 Diabetes
- Being tested
- Screening and studying characteristics
- Keywords
- NAFLD, NAFLD, characteristics, type 2 diabetes, hospital
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and studying characteristicsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus patients | Other | Not described Receives: Other: Screening and studying characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
VCTEM (KPa) measure
The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined.
Measured: up to year four
CAPTM (dB/m) measure
The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.
Measured: up to year four
Liver Ultrasound
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.
Measured: up to year four
Liver biopsy
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.
Measured: up to year four
Aspartate transaminase (AST)
Out of the EPF the blood parameter AST (U/L) will be collected
Measured: up to year four
Alanine transaminase (ALT)
Out of the EPF the blood parameter ALT (U/L) will be collected.
Measured: up to year four
Gamma glutamyltransferase (GGT)
Out of the EPF the blood parameter GGT (U/L) will be collected.
Measured: up to year four
Lactate dehydrogenase (LDH)
Out of the EPF the blood parameter LDH (U/L) will be collected.
Measured: up to year four
total protein
Out of the EPF the blood parameter total protein (g/L) will be collected.
Measured: up to year four
Albumin
Out of the EPF the blood parameter albumin (mg/dL) will be collected.
Measured: up to year four
Ferritin
Out of the EPF the blood parameter ferritin (µg/L) will be collected.
Measured: up to year four
bilirubin total
Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected.
Measured: up to year four
Exclusion of other liver diseases
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.
Measured: up to year four
Weight
The weight (kg)
Measured: up to year four
Height
The height (m)
Measured: up to year four
BMI (Body Mass Index)
The weight (kg) and height (m) will be determined and from this the BMI (kg/m²) will be calculated.
Measured: up to year four
waist circumference
The waist circumference will be measured and noted in cm.
Measured: up to year four
Wellbeing - BAECKE
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.
Measured: up to year four
Wellbeing - GAD-7
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.
Measured: up to year four
Wellbeing - PHQ-9
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.
Measured: up to year four
Wellbeing - WPAI-SHP
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.
Measured: up to year four
Wellbeing - SF-36
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.
Measured: up to year four
Diagnosis Diabetes
The year of diagnosis is asked to the patient (yr).
Measured: up to year four
Diabetes complications
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.
Measured: up to year four
Secondary outcomes (14)
concomitant medication
The medication use will be noted in the CRF
Measured: up to year four
serum creatine
serum creatine (mg/dL)
Measured: up to year four
urine creatine
urine creatine (mg/dL)
Measured: up to year four
micro-albumin
micro-albumin (mg/dL)
Measured: up to year four
albumin/creatine ratio
albumin/creatine ratio (mg/g creat)
Measured: up to year four
estimated glomerular filtration rate
estimated glomerular filtration rate (ml/min/1,73m²).
Measured: up to year four
Triglycerides (mg/dL)
Triglycerides (mg/dL) in blood
Measured: up to year four
HDL (mg/dL)
HDL (mg/dL) in blood
Measured: up to year four
LDL cholesterol (mg/dL)
LDL cholesterol (mg/dL) in blood
Measured: up to year four
Total cholesterol (mg/dL).
Total cholesterol (mg/dL) in blood
Measured: up to year four
thrombocytes
thrombocytes (1000/µL) in blood
Measured: up to year four
fasting glucose (mg/dL)
fasting glucose (mg/dL) in blood
Measured: up to year four
partial alpha fetoprotein (AFP)
partial alpha fetoprotein (AFP) in blood
Measured: up to year four
haemoglobin A1c (%)
haemoglobin A1c (%) in blood
Measured: up to year four
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Jan 2020
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu Struyve, Hasselt University
- Investigators
- Geert Robaeys, prof. dr., Principal investigator, Hasselt UniversityLeen Heyens, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999124
- Sponsor's protocol ID
- NaDiA-01
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04999124
- Acronym / sponsor ID
- NaDiA-01
- Conditions
- Non-Alcoholic Fatty Liver Disease, Type2 Diabetes
- Keywords
- NAFLD, NAFLD, characteristics, type 2 diabetes, hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,762 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus patients | Other | Other: Screening and studying characteristics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years,
- having type 2 diabetes,
- able to understand Dutch,
- able to understand the informed consent
Key exclusion criteria (3 listed)
- excessive alcohol abuse,
- other liver disease,
- secondary causes of steatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and studying characteristicsType 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. | Other | Type 2 Diabetes Mellitus patients |
Primary outcome
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.
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.
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.
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.
Aspartate transaminase (AST)
Time frame: up to year four
Out of the EPF the blood parameter AST (U/L) will be collected
Alanine transaminase (ALT)
Time frame: up to year four
Out of the EPF the blood parameter ALT (U/L) will be collected.
Gamma glutamyltransferase (GGT)
Time frame: up to year four
Out of the EPF the blood parameter GGT (U/L) will be collected.
Lactate dehydrogenase (LDH)
Time frame: up to year four
Out of the EPF the blood parameter LDH (U/L) will be collected.
total protein
Time frame: up to year four
Out of the EPF the blood parameter total protein (g/L) will be collected.
Albumin
Time frame: up to year four
Out of the EPF the blood parameter albumin (mg/dL) will be collected.
Ferritin
Time frame: up to year four
Out of the EPF the blood parameter ferritin (µg/L) will be collected.
bilirubin total
Time frame: up to year four
Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected.
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.
Weight
Time frame: up to year four
The weight (kg)
Height
Time frame: up to year four
The height (m)
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.
waist circumference
Time frame: up to year four
The waist circumference will be measured and noted in cm.
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.
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.
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.
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.
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.
Diagnosis Diabetes
Time frame: up to year four
The year of diagnosis is asked to the patient (yr).
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.
14 secondary outcomes
concomitant medication
Time frame: up to year four
serum creatine
Time frame: up to year four
urine creatine
Time frame: up to year four
micro-albumin
Time frame: up to year four
albumin/creatine ratio
Time frame: up to year four
estimated glomerular filtration rate
Time frame: up to year four
Triglycerides (mg/dL)
Time frame: up to year four
HDL (mg/dL)
Time frame: up to year four
LDL cholesterol (mg/dL)
Time frame: up to year four
Total cholesterol (mg/dL).
Time frame: up to year four
thrombocytes
Time frame: up to year four
fasting glucose (mg/dL)
Time frame: up to year four
partial alpha fetoprotein (AFP)
Time frame: up to year four
haemoglobin A1c (%)
Time frame: up to year four
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Robaeys, prof. dr. principal investigator
Hasselt University
Leen Heyens, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and studying characteristics in people with Non-Alcoholic Fatty Liver Disease and Type2 Diabetes, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VCTEM (KPa) measure (time frame: up to year four). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.