Characteristics of NAFLD Among Type 2 Diabetes Patients

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Type2 Diabetes
• Interventions: Other: Screening and studying characteristics

• Registration Number: NCT04999124
• Lead Sponsor: Ziekenhuis Oost-Limburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes Mellitus patients	Screening and studying characteristics	-

Primary Outcome Measures

Name	Time	Method
Diagnosis Diabetes	up to year four	The year of diagnosis is asked to the patient (yr).
CAPTM (dB/m) measure	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.
Lactate dehydrogenase (LDH)	up to year four	Out of the EPF the blood parameter LDH (U/L) will be collected.
Albumin	up to year four	Out of the EPF the blood parameter albumin (mg/dL) will be collected.
BMI (Body Mass Index)	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	up to year four	The waist circumference will be measured and noted in cm.
Liver biopsy	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)	up to year four	Out of the EPF the blood parameter AST (U/L) will be collected
Alanine transaminase (ALT)	up to year four	Out of the EPF the blood parameter ALT (U/L) will be collected.
total protein	up to year four	Out of the EPF the blood parameter total protein (g/L) will be collected.
Wellbeing - PHQ-9	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	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.
Diabetes complications	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.
VCTEM (KPa) measure	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.
Liver Ultrasound	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.
Ferritin	up to year four	Out of the EPF the blood parameter ferritin (µg/L) will be collected.
Height	up to year four	The height (m)
Wellbeing - SF-36	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.
Gamma glutamyltransferase (GGT)	up to year four	Out of the EPF the blood parameter GGT (U/L) will be collected.
bilirubin total	up to year four	Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected.
Exclusion of other liver diseases	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	up to year four	The weight (kg)
Wellbeing - BAECKE	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium