Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases

Technische Universität Dresden1 site in 1 country180 target enrollmentOctober 16, 2023

ConditionsNAFLD Diabetes Mellitus Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: NAFLD
Sponsor: Technische Universität Dresden
Enrollment: 180
Locations: 1
Primary Endpoint: Qualitative differences in platelets
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this cross-sectional observational study is to to perform a thorough characterization of the quantitative and qualitative differences in peripheral blood cells, and circulating factors (proteins, metabolites, lipids, extracellular vesicles) in different stages of several metabolic diseases (diabetes, obesity, non-alcoholic fatty liver disease) that share common pathophysiological mechanisms and in comparison with adult healthy controls. The main question[s] it aims to answer are:

Which are the quantitative (number and concentration) and qualtitative (characteristics, functional assays) differences in platelets in patients with metabolic diseases vs subjects without metabolic diseases
Which are the quantitative (number and concentration) and qualtitative (characteristics, functional assays) differences in leucocytes or circulating molecules in patients with metabolic diseases vs subjects without metabolic diseases

Registry

clinicaltrials.gov

Start Date

October 16, 2023

End Date

December 31, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Technische Universität Dresden

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years old
•Additional inclusion criteria for case groups:
•High risk group for significant liver fibrosis
•FIB-4 score ≥ 1.3 AND
•Fibroscan measurement ≥ 8kPa
•Steatotic Liver Disease group
•Diagnosis of steatosis in ultrasound AND CAP \> 275 dB/m
•Prediabetes
•HbA1c \>5.7 AND \<6.5% OR/AND
•Fasting Glucose 100-125 mg/dl OR/AND

Exclusion Criteria

•Diabetes mellitus Typ 1
•BMI \< 18.5 kg/m2
•Transfusion of blood or major bleeding in the last six months
•Anaemia with haemoglobin \< 9,0 g/dl
•Chronic alcohol or drug abuse
•Presence of any acute or chronic liver disease apart from non-alcoholic fatty liver disease (i.e. viral, autoimmune or alcoholic hepatitis, haemochromatosis, Morbus Wilson etc.)
•Systemic infections (CRP \> 1 mg/dl)
•Medications that affect blood glucose levels (e.g. antidiabetics \[except from the subjects forming the diabetes group\], steroids) in the last six months
•Medications that affect coagulation (e.g. anticoagulants and antiplatelet agents) in the last six months
•Medications that affect immune function (e.g. immunosuppressive drugs) in the last six months