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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

∙ 1\. Age \> 18 years old

∙ Additional inclusion criteria for case groups:

• High risk group for significant liver fibrosis

• 1\. FIB-4 score ≥ 1.3 AND 2. Fibroscan measurement ≥ 8kPa

• Steatotic Liver Disease group

• 1\. 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

⁃ Glucose at 120 min of OGTT between 140-200 mg/dl

• Diabetes 1. HbA1c ≥ 6.5% OR/AND 2. Fasting Glucose \> 126 mg/dl OR/AND 3. Glucose at 120 min of OGTT \> 200 mg/dl

• If a subject does not fulfil the additional criteria for participating in a case group, then he/she will be included in the respective control group which will be:

• A#) Low risk for significant liver fibrosis 1. Fibroscan measurements \< 8kPa B#) No steatosis group

• 1\. No steatosis in liver ultrasound AND CAP ≤ 275 dB/m C#) Normal glucose tolerance test group

⁃ HbA1c \< 5.7% AND

⁃ Fasting glucose \< 100 mg/dl AND

⁃ Glucose at 120 min of OGTT \<140 mg/dl

Locations
Other Locations
Germany
University Study Center for Metabolic Diseases
RECRUITING
Dresden
Contact Information
Primary
Nikolaos Perakakis, MD
Nikolaos.Perakakis@ukdd.de
+4935145813651
Backup
Ingo Weigmann, MD
Ingo.Weigmann@ukdd.de
+4935145811723
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 180
Treatments
High risk - Liver Fibrosis
1. FIB-4 score ≥ 1.3 AND~2. Fibroscan measurement ≥ 8kPa
Low risk - Liver Fibrosis
Fibroscan measurements \< 8kPa
Steatotic Liver Disease
Diagnosis of steatosis in ultrasound AND CAP \> 275 dB/m
No Steatotic Liver Disease
No steatosis in liver ultrasound AND CAP ≤ 275 dB/m
Diabetes
1. HbA1c ≥ 6.5% OR/AND~2. Fasting Glucose \> 126 mg/dl OR/AND~3. Glucose at 120 min of OGTT \> 200 mg/dl AND/OR history of Diabetes, treated with at least one antidiabetic medication
Prediabetes
1. HbA1c \>5.7 AND \<6.5% OR/AND~2. Fasting Glucose 100-125 mg/dl OR/AND~3. Glucose at 120 min of OGTT between 140-200 mg/dl
Normal glucose tolerance
1. HbA1c \< 5.7% AND~2. Fasting glucose \< 100 mg/dl AND~3. Glucose at 120 min of OGTT \<140 mg/dl and no history of Diabetes
Sponsors
Leads: Technische Universität Dresden

This content was sourced from clinicaltrials.gov