NCT06396871

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• NAFLD
• Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oral glucose tolerance test	75g of a standardized glucose solution followed by blood draw at 0, 30, 60, 90, 120 min
DIAGNOSTIC_TEST	Liver Ultrasound	A crude assessment of liver status in order to identify the presence of steatosis or not will take place with ultrasound.
DIAGNOSTIC_TEST	Fibroscan of the Liver	FibroScan non-invasively measures the stiffness of the liver by capturing and calculating the speed of a shear wave as it travels through the liver (vibration controlled transient elastography).
DIAGNOSTIC_TEST	Magentic Resonance Imaging (MRI) of the liver	The exact calculation of liver fat with proton density fat fraction will take place with MRI.

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-05-02
• Last updated: 2024-05-02

Locations

1 site across 1 country: Germany