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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Type 1 Diabetes; Non-alcoholic Fatty Liver Disease; Glycogen Hepatopathy

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
    • Contact: Silvia Ballesta; Phone Number: 3902 + 34 932 48 30 00; Email: SBallesta@psmar.cat
  • Barcelona
    • Vilafranca Del Penedès, Barcelona, Spain, 08720
      • Recruiting
      • Hospital Comarcal de L'Alt Penedés
      • Contact: Silvia Ballesta; Phone Number: 1027 9381810440; Email: sballesta@csap.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Descriptive observational study of prevalence (cross-sectional) in patients with T1D of the healthcare area of the Hospital del Mar and Hospital de Vilafranca (Barcelona).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
To study the relationship between metabolic liver diseases in patients with T1D and the degree of metabolic control of diabetes.	2 years
To study the relationship between metabolic liver diseases in patients with T1D and the presence of metabolic syndrome.	2 years
To study the relationship between metabolic liver diseases in patients with T1D and the presence of microvascular and macrovascular complications.	2 years

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 21-E5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No