Role of Regulatory B Cells in the Pathogenesis of Metabolic Associated Fatty Liver Disease

NCT04720560 | Recruiting

• 1 other identifier: MAFLD
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease patients.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease

  To evaluate the role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease patients.

  baseline

Interventions

regulatory B cell by flow cytometry DIAGNOSTIC_TEST

4-Evaluation of the Frequency of regulatory B cells (Bregs) by Flow Cytometry Using flow cytometry, circulating Bregs will be detected using FITC-conjugated-CD38, PE-conjugated-CD24 (Bioscience, USA), and PerCP-conjugated CD19 (BD Bioscience, USA). Briefly, 100 µl of blood sample will be incubated with 10 µL of CD24, CD38 and CD19 for 20 minutes at 4 °C in the dark. Following incubation, RBCs will be lysed and washed. Cells will be fixed and permeabilized then stained with APC-conjugated IL-10 (BD Bioscience, San Jose, CA, USA) and analysis will be done by FACS Calibur flow cytometry with CellQuest software (Becton Dickinson Biosciences, San Jose, CA, USA). An isotype-matched negative control will be used for each sample. Forward and side scatter histograms will be used to define the lymphocytes population. CD19+ IL-10+ B cells will be gated, then the expression of CD38 and CD24 on the CD19+B cells will be detected. Bregs will be identified as CD19+ IL-10+CD24+hiCD38+hi cells.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. After obtaining the appropriate consents, data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake). 2. Imaging techniques, such as ultrasonography (US), fibroscan with CAP and/or computed topography (CT) and /or MRI. 3. Blood samples will be collected for liver function tests, lipid profile and CRP. 4. Evaluation of the Frequency of regulatory B cells (Bregs) by Flow Cytometry 5. Six measurements will be obtained (sex, age, height, weight, body mass index, and abdominal girth, waist circumference). Calculation of fatty liver index, (FLI) will be done. The fatty liver index (FLI), is an algorithm based on waist circumference, body mass index (BMI), triglyceride, and gamma-glutamyl-transferase (GGT).

You may qualify if:

• All patients aged \>18 years old and was diagnosed as fatty liver based on clinical examination, laboratory investigations and imaging techniques.

You may not qualify if:

• Patients aged ≤18 years old. 2-Pregnancy. 3-Presence of malignancy. 4-Type I DM. 5-Fatty liver patients on treatment by statin derivatives or other medications. 6- Fatty liver patients undergone bariatric surgeries.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Medicine

Asyut, Egypt

RECRUITING

Related Publications (1)

• Vilar-Gomez E, Chalasani N. Non-invasive assessment of non-alcoholic fatty liver disease: Clinical prediction rules and blood-based biomarkers. J Hepatol. 2018 Feb;68(2):305-315. doi: 10.1016/j.jhep.2017.11.013. Epub 2017 Dec 2.

  PMID: 29154965 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Amira Mohamed, PhD

CONTACT

0101276047; amiramohmad60@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 22, 2021
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)