Actively Recruiting
Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
Led by Technische Universität Dresden · Updated on 2024-05-02
180
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years old
- High risk for significant liver fibrosis with FIB-4 score ≥ 1.3 and Fibroscan measurement ≥ 8kPa (for case group)
- Steatotic liver disease with diagnosis of steatosis in ultrasound and CAP > 275 dB/m (for case group)
- Prediabetes defined by HbA1c >5.7% and <6.5%, or fasting glucose 100-125 mg/dl, or glucose at 120 min of OGTT between 140-200 mg/dl (for case group)
- Diabetes defined by HbA1c ≥ 6.5%, or fasting glucose > 126 mg/dl, or glucose at 120 min of OGTT > 200 mg/dl (for case group)
- Control groups include low risk for liver fibrosis with Fibroscan < 8kPa, no steatosis with ultrasound CAP ≤ 275 dB/m, and normal glucose tolerance with HbA1c < 5.7%, fasting glucose < 100 mg/dl, and glucose at 120 min of OGTT < 140 mg/dl
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- Body mass index (BMI) less than 18.5 kg/m²
- Blood transfusion or major bleeding in the last six months
- Anemia with hemoglobin less than 9.0 g/dl
- Chronic alcohol or drug abuse
- Any acute or chronic liver disease other than non-alcoholic fatty liver disease
- Systemic infections with CRP > 1 mg/dl
- Use of medications affecting blood glucose in the last six months (except in diabetes group)
- Use of anticoagulants or antiplatelet agents in the last six months
- Use of immunosuppressive drugs in the last six months
- Pregnancy or breastfeeding
- Severe psychiatric disorders
- Inability to follow the study protocol
- Any medical condition considered unsuitable for the study by the investigator
- Additional MRI exclusions: pacemaker, artificial heart valve, metal prosthesis, magnetic implants, spirals, fixed metal dental braces, acupuncture needles, insulin pumps, tattoos or permanent eyeliner (if MRI > 3 Tesla), claustrophobia, psychiatric conditions preventing participation, or body size incompatible with MRI performance
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Study Center for Metabolic Diseases
Dresden, Saxony, Germany, 01307
Actively Recruiting
Research Team
N
Nikolaos Perakakis, MD
CONTACT
I
Ingo Weigmann, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
7
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