Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

Official title:

Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus: Non-alcoholic Fatty Liver Disease and Glycogenic Hepatopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054712
• Other study ID #: 21-E5
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2021
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Nonalcoholic fatty liver disease (NAFLD) has been extensively studied in the context of type 2 diabetes mellitus (T2D) due to its higher prevalence and its association with obesity and syndrome metabolic, a well-established risk factor for NAFLD. Although several studies have reported the accumulation of liver fat in patients with type 1 diabetes mellitus (T1D), the prevalence, etiology, and the consequences of NAFLD in patients with T1D are poorly characterized, requiring more studies in this field. In addition, liver involvement at the metabolic level in patients with T1D raises the differential diagnosis between NAFLD and glycogen hepatopathy (GH), a rare complication associated with the poorly metabolic control of diabetes and probably underdiagnosed, since the ultrasound pattern is the same than the NAFLD. The investigators have designed a cross-sectional observational study with the objective of describing the prevalence of metabolic liver diseases (NAFLD and GH) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca, as well as studying the relationship of these pathologies with the degree of metabolic control, the presence of metabolic syndrome and the presence of micro and macrovascular complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Men and women aged = 18 years.

• Diagnosed with T1D of at least 6 months of evolution.

• Patients who give their informed consent in writing.

Exclusion Criteria:

• Active alcoholism> 30 g / day in men and> 20 g / day in women.

• Known non-metabolic liver disease: alcoholic hepatitis, viral hepatitis from HBV infection and / or HCV, hemochromatosis, Wilson's disease, a-1 antitrypsin deficiency, autoimmune hepatitis, hepatic granulomatous (tuberculosis, mycobacteria, histoplasmosis), hepatic lymphoma, primary neoplasia liver, liver metastasis.

• Active treatment with hepatotoxic drugs: amiodarone, isoniazid, rifampicin, sulfa drugs, tetracyclines, amoxycline / clavulanate, ketoconazole, methotrexate, valproic acid, trazodone, tamoxifen, methyldopa, reverse transcriptase inhibitors, chemotherapy, immunotherapy.

• Pregnant women.

• Acute decompensation of T1D (ketoacidosis) in the 3 months prior to inclusion. The inclusion after this period.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Type 1 Diabetes

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Comarcal de l'Alt Penedès	Vilafranca Del Penedès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches in the population of patients with T1D.	To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches (levels of transaminases, liver ultrasound, liver MRI and, in selected cases, liver biopsy) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca.	2 years
Secondary	To study the relationship between metabolic liver diseases in patients with T1D and the degree of metabolic control of diabetes.		2 years
Secondary	To study the relationship between metabolic liver diseases in patients with T1D and the presence of metabolic syndrome.		2 years
Secondary	To study the relationship between metabolic liver diseases in patients with T1D and the presence of microvascular and macrovascular complications.		2 years