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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to explore the differences in blood cells and circulating molecules in adults with metabolic diseases such as diabetes, obesity, and non-alcoholic fatty liver disease compared to healthy adults. The study aims to measure both the quantity and characteristics of platelets, leukocytes, and other circulating factors to better understand these conditions' shared underlying mechanisms. Participants will be assessed across several groups based on liver fibrosis risk, steatosis presence, and glucose metabolism status. Diagnostic tests include a 75g oral glucose tolerance test with multiple timed blood draws, liver ultrasound to detect fat accumulation, FibroScan to measure liver stiffness, and MRI to precisely quantify liver fat. These tests help categorize participants and evaluate differences in blood components. During the study, participants undergo blood sample collections and various diagnostic scans on the same day to assess platelet and white blood cell qualities and quantities. Researchers will analyze markers like neutrophil and monocyte function, various interleukins, and other blood factors. The study monitors these outcomes within one day of testing, aiming to deepen understanding of metabolic disease impacts on blood and liver health.
CONDITIONS
Brief Title
Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- High risk for significant liver fibrosis with FIB-4 score ≥ 1.3 and Fibroscan ≥ 8 kPa
- Diagnosis of steatosis by ultrasound and CAP > 275 dB/m
- Prediabetes defined by HbA1c between 5.7% and 6.5%, or fasting glucose 100-125 mg/dl, or glucose at 120 min of OGTT between 140-200 mg/dl
- Diabetes defined by HbA1c ≥ 6.5%, or fasting glucose > 126 mg/dl, or glucose at 120 min of OGTT > 200 mg/dl
- Participants not meeting case group criteria may be included in control groups with low liver fibrosis risk or normal glucose tolerance
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 below 9.0 g/dl
- Chronic alcohol or drug abuse
- Acute or chronic liver diseases other than non-alcoholic fatty liver disease
- Systemic infections with CRP above 1 mg/dl
- Use of medications affecting blood glucose, coagulation, or immune function in the last six months (except antidiabetics in diabetes group)
- Pregnancy or breastfeeding
- Severe psychiatric disorders
- Inability to follow study protocol
- Any medical condition unsuitable for study inclusion per investigator opinion
- MRI-specific exclusions including pacemaker, metal implants, claustrophobia, and others preventing MRI completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo several diagnostic tests including an oral glucose tolerance test, liver ultrasound, Fibroscan, and liver MRI to assess liver status and metabolic health.
1 day of testing including multiple blood draws and imaging
Duration - Up to 4 years
Participants are observed to understand metabolic and liver disease progression without active intervention.
Follow-up visits as scheduled by the study team
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
I
Ingo Weigmann, MD
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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