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

NCT ID: NCT05054712

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-01-01

Brief 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.

Conditions

Non-alcoholic Fatty Liver Disease; Glycogen Hepatopathy; Type 1 Diabetes; Liver Diseases

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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, α-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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Comarcal de l'Alt Penedès

Vilafranca del Penedès, Barcelona, Spain

Site Status: RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Silvia Ballesta

Role: primary

sballesta@csap.cat

9381810440 ext. 1027

Silvia Ballesta

Role: primary

SBallesta@psmar.cat

+ 34 932 48 30 00 ext. 3902

Other Identifiers

21-E5

Identifier Type: -

Identifier Source: org_study_id