Characteristics of NAFLD Among Type 2 Diabetes Patients

Non-Alcoholic Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999124
• Other study ID #: NaDiA-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: March 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: Geert Robaeys, prof. dr.
• Phone: +32 89 32 65 05
• Email: geert.robaeys[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Aspartate transaminase (AST)	Out of the EPF the blood parameter AST (U/L) will be collected	up to year four
Primary	Alanine transaminase (ALT)	Out of the EPF the blood parameter ALT (U/L) will be collected.	up to year four
Primary	Gamma glutamyltransferase (GGT)	Out of the EPF the blood parameter GGT (U/L) will be collected.	up to year four
Primary	Lactate dehydrogenase (LDH)	Out of the EPF the blood parameter LDH (U/L) will be collected.	up to year four
Primary	total protein	Out of the EPF the blood parameter total protein (g/L) will be collected.	up to year four
Primary	Albumin	Out of the EPF the blood parameter albumin (mg/dL) will be collected.	up to year four
Primary	Ferritin	Out of the EPF the blood parameter ferritin (µg/L) will be collected.	up to year four
Primary	bilirubin total	Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected.	up to year four
Primary	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
Primary	Weight	The weight (kg)	up to year four
Primary	Height	The height (m)	up to year four
Primary	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
Primary	waist circumference	The waist circumference will be measured and noted in cm.	up to year four
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Diagnosis Diabetes	The year of diagnosis is asked to the patient (yr).	up to year four
Primary	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	concomitant medication	The medication use will be noted in the CRF	up to year four
Secondary	serum creatine	serum creatine (mg/dL)	up to year four
Secondary	urine creatine	urine creatine (mg/dL)	up to year four
Secondary	micro-albumin	micro-albumin (mg/dL)	up to year four
Secondary	albumin/creatine ratio	albumin/creatine ratio (mg/g creat)	up to year four
Secondary	estimated glomerular filtration rate	estimated glomerular filtration rate (ml/min/1,73m²).	up to year four
Secondary	Triglycerides (mg/dL)	Triglycerides (mg/dL) in blood	up to year four
Secondary	HDL (mg/dL)	HDL (mg/dL) in blood	up to year four
Secondary	LDL cholesterol (mg/dL)	LDL cholesterol (mg/dL) in blood	up to year four
Secondary	Total cholesterol (mg/dL).	Total cholesterol (mg/dL) in blood	up to year four
Secondary	thrombocytes	thrombocytes (1000/µL) in blood	up to year four
Secondary	fasting glucose (mg/dL)	fasting glucose (mg/dL) in blood	up to year four
Secondary	partial alpha fetoprotein (AFP)	partial alpha fetoprotein (AFP) in blood	up to year four
Secondary	haemoglobin A1c (%)	haemoglobin A1c (%) in blood	up to year four