Clinical trial NCT04999124: Characteristics of NAFLD Among Type 2 Diabetes Patients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Type2 Diabetes
Keywords: NAFLD
NAFLD, characteristics
type 2 diabetes
hospital
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: VCTEM (KPa) measure
timeFrame: up to year four
measure: CAPTM (dB/m) measure
timeFrame: up to year four
measure: Liver Ultrasound
timeFrame: up to year four
measure: Liver biopsy
timeFrame: up to year four
measure: Aspartate transaminase (AST)
timeFrame: up to year four
measure: Alanine transaminase (ALT)
timeFrame: up to year four
measure: Gamma glutamyltransferase (GGT)
timeFrame: up to year four
measure: Lactate dehydrogenase (LDH)
timeFrame: up to year four
measure: total protein
timeFrame: up to year four
measure: Albumin
timeFrame: up to year four
measure: Ferritin
timeFrame: up to year four
measure: bilirubin total
timeFrame: up to year four
measure: Exclusion of other liver diseases
timeFrame: up to year four
measure: Weight
timeFrame: up to year four
measure: Height
timeFrame: up to year four
measure: BMI (Body Mass Index)
timeFrame: up to year four
measure: waist circumference
timeFrame: up to year four
measure: Wellbeing - BAECKE
timeFrame: up to year four
measure: Wellbeing - GAD-7
timeFrame: up to year four
measure: Wellbeing - PHQ-9
timeFrame: up to year four
measure: Wellbeing - WPAI-SHP
timeFrame: up to year four
measure: Wellbeing - SF-36
timeFrame: up to year four
measure: Diagnosis Diabetes
timeFrame: up to year four
measure: Diabetes complications
timeFrame: up to year four
Secondary outcomes:
measure: concomitant medication
timeFrame: up to year four
measure: serum creatine
timeFrame: up to year four
measure: urine creatine
timeFrame: up to year four
measure: micro-albumin
timeFrame: up to year four
measure: albumin/creatine ratio
timeFrame: up to year four
measure: estimated glomerular filtration rate
timeFrame: up to year four
measure: Triglycerides (mg/dL)
timeFrame: up to year four
measure: HDL (mg/dL)
timeFrame: up to year four
measure: LDL cholesterol (mg/dL)
timeFrame: up to year four
measure: Total cholesterol (mg/dL).
timeFrame: up to year four
measure: thrombocytes
timeFrame: up to year four
measure: fasting glucose (mg/dL)
timeFrame: up to year four
measure: partial alpha fetoprotein (AFP)
timeFrame: up to year four
measure: haemoglobin A1c (%)
timeFrame: up to year four
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Leen Heyens, drs.
role: STUDY_CHAIR
References: