Characteristics of NAFLD Among Type 2 Diabetes Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Type2 Diabetes; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Screening and studying characteristics

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geert Robaeys, prof. dr.; Phone Number: +32 89 32 65 05; Email: geert.robaeys@zol.be
• Study Contact Backup: Name: Leen Heyens, drs.; Phone Number: +32 89 21 20 55; Email: leen.heyens@uhasselt.be

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Leen Heyens, drs.; Phone Number: +32 21 20 55; Email: leen.heyens@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Type 2 Diabetes Mellitus patients	Other: Screening and studying characteristics; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
concomitant medication	The medication use will be noted in the CRF	up to year four
serum creatine	serum creatine (mg/dL)	up to year four
urine creatine	urine creatine (mg/dL)	up to year four
micro-albumin	micro-albumin (mg/dL)	up to year four
albumin/creatine ratio	albumin/creatine ratio (mg/g creat)	up to year four
estimated glomerular filtration rate	estimated glomerular filtration rate (ml/min/1,73m²).	up to year four
Triglycerides (mg/dL)	Triglycerides (mg/dL) in blood	up to year four
HDL (mg/dL)	HDL (mg/dL) in blood	up to year four
LDL cholesterol (mg/dL)	LDL cholesterol (mg/dL) in blood	up to year four
Total cholesterol (mg/dL).	Total cholesterol (mg/dL) in blood	up to year four
thrombocytes	thrombocytes (1000/µL) in blood	up to year four
fasting glucose (mg/dL)	fasting glucose (mg/dL) in blood	up to year four
partial alpha fetoprotein (AFP)	partial alpha fetoprotein (AFP) in blood	up to year four
haemoglobin A1c (%)	haemoglobin A1c (%) in blood	up to year four

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Collaborators: Ziekenhuis Oost-Limburg
• Investigators: Study Chair: Leen Heyens, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: type 2 diabetes; NAFLD; hospital; NAFLD, characteristics
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NaDiA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No