Characteristics of NAFLD Among Type 2 Diabetes Patients

NCT04999124 | Active Not Recruiting

• 1 other identifier: NaDiA-01
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease; Type2 Diabetes

Keywords

NAFLD; NAFLD, characteristics; type 2 diabetes; hospital

Outcome Measures

Primary Outcomes (24)

• VCTEM (KPa) measure

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

  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.

  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.

  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.

  up to year four

• Aspartate transaminase (AST)

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

  up to year four

• Alanine transaminase (ALT)

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

  up to year four

• Gamma glutamyltransferase (GGT)

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

  up to year four

• Lactate dehydrogenase (LDH)

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

  up to year four

• total protein

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

  up to year four

• Albumin

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

  up to year four

• Ferritin

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

  up to year four

• bilirubin total

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

  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.

  up to year four

• Weight

  The weight (kg)

  up to year four

• Height

  The height (m)

  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.

  up to year four

• waist circumference

  The waist circumference will be measured and noted in cm.

  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.

  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.

  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.

  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.

  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.

  up to year four

• Diagnosis Diabetes

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

  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.

  up to year four

Secondary Outcomes (14)

• concomitant medication

  up to year four

• serum creatine

  up to year four

• urine creatine

  up to year four

• micro-albumin

  up to year four

• albumin/creatine ratio

  up to year four

Study Arms (1)

Type 2 Diabetes Mellitus patients

OTHER

Other: Screening and studying characteristics

Interventions

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.

Type 2 Diabetes Mellitus patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Geert Robaeys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Leen Heyens, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: August 10, 2021
• Study Start: January 1, 2020
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)