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NCT06445361 Clinical Trial

Prevalence of NAFLD in T1DM Patients

Type 1 Diabetes Clinical Trial

— PAD1ZOL  

Official title:
The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 1 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06445361
Other study ID # Z-2022007
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date November 1, 2024

Study information
Verified date May 2024
Source Ziekenhuis Oost-Limburg
Contact Leen Heyens, MsC
Phone 089 21 20 55
Email nafldstudie@zol.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the prevalence of NAFLD in T1DM patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 138
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - T1DM - = 18 years of age - Written informed consent obtained Exclusion Criteria: - Excessive alcohol use - Exclusion of other causes of liver disease and secondary causes of liver steatosis

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• FibroScan
Performance of a FibroScan measurement to determine steatosis and fibrosis.

Locations
Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk Limburg

Sponsors (1)
Lead Sponsor Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of NAFLD in T1DM To determine the prevalence of steatosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with controlled attenuation parameter (CAP) measurements. During the intervention
Primary Prevalence of fibrosis in T1DM To determine the prevalence of fibrosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with vibration controlled attenuation parameter (VCTE) measurements. During the intervention
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