NCT05054712

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

September 13, 2021

Last Update Submit

September 22, 2021

Conditions

Non-alcoholic Fatty Liver DiseaseGlycogen HepatopathyType 1 DiabetesLiver Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Men and women aged ≥ 18 years.
  • Diagnosed with T1D of at least 6 months of evolution.
  • Patients who give their informed consent in writing.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Comarcal de l'Alt Penedès

Vilafranca del Penedès, Barcelona, 08720, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseDiabetes Mellitus, Type 1Liver Diseases

Condition Hierarchy (Ancestors)

Fatty LiverDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 23, 2021

Study Start

September 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)