Diabetes Mellitus, NAFLD, Obesity
Conditions
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
Interventions
DIAGNOSTIC_TESTOral glucose tolerance test
75g of a standardized glucose solution followed by blood draw at 0, 30, 60, 90, 120 min
DIAGNOSTIC_TESTLiver Ultrasound
A crude assessment of liver status in order to identify the presence of steatosis or not will take place with ultrasound.
DIAGNOSTIC_TESTFibroscan 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_TESTMagentic Resonance Imaging (MRI) of the liver
The exact calculation of liver fat with proton density fat fraction will take place with MRI.
Sponsors
Technische Universität Dresden
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1\. Age \> 18 years old Additional inclusion criteria for case groups: 1. High risk group for significant liver fibrosis 1\. FIB-4 score ≥ 1.3 AND 2. Fibroscan measurement ≥ 8kPa 2. Steatotic Liver Disease group 1\. Diagnosis of steatosis in ultrasound AND CAP \> 275 dB/m 3. 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 4. 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 1. HbA1c \< 5.7% AND 2. Fasting glucose \< 100 mg/dl AND 3. Glucose at 120 min of OGTT \<140 mg/dl
Exclusion criteria
1. Diabetes mellitus Typ 1 2. BMI \< 18.5 kg/m2 3. Transfusion of blood or major bleeding in the last six months 4. Anaemia with haemoglobin \< 9,0 g/dl 5. Chronic alcohol or drug abuse 6. 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.) 7. Systemic infections (CRP \> 1 mg/dl) 8. Medications that affect blood glucose levels (e.g. antidiabetics \[except from the subjects forming the diabetes group\], steroids) in the last six months 9. Medications that affect coagulation (e.g. anticoagulants and antiplatelet agents) in the last six months 10. Medications that affect immune function (e.g. immunosuppressive drugs) in the last six months 11. Pregnancy or breastfeeding 12. Severe psychic disorders 13. Inability to follow the study protocol 14. Have any medical condition unsuitable for inclusion in the study, in the opinion of the investigator Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative differences in platelets | 1 day | % of Platelet aggregation |
| Quantitative differences in platelets | 1 day | Platelet count in GPt/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative differences in lymphocytes | 1 day | Lymphocyte count in GPt/L |
| Quantitative differences in monocytes | 1 day | Monocyte count in GPt/L |
| Qualitative differences in neutrophils in NETosis | 1 day | % of neutrophils performing NETosis (FACS analysis) |
| Quantitative differences in leukocytes | 1 day | Leucocyte count in GPt/L |
| Qualitative differences in monocytes | 1 day | % of monocytes performing phagocytosis (FACS analysis) |
| Quantitative differences in Interleukin-6 | 1 day | Interleukin-6 in pg/ml |
| Quantitative differences in Interleukin-8 | 1 day | Interleukin-8 in pg/ml |
| Qualitative differences in neutrophils in phagocytosis | 1 day | % of neutrophils performing phagocytosis (FACS analysis) |
| Quantitative differences in neutrophils | 1 day | Neutrophil count in GPt/L |
Countries
Germany
Contacts
Primary ContactNikolaos Perakakis, MD
Backup ContactIngo Weigmann, MD
Outcome results
None listed