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

Prior treatment

• Chronic alcohol or drug abuse
• Medications that affect coagulation (e.g. anticoagulants and antiplatelet agents) in the last six months
• Medications that affect immune function (e.g. immunosuppressive drugs) in the last six months

Other illness

• Diabetes mellitus Typ 1
• Transfusion of blood or major bleeding in the last six months
• 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.)
• Severe psychic disorders
• Have any medical condition unsuitable for inclusion in the study, in the opinion of the investigator
  • Additional exclusion criteria for MRI:
• Artificial heart valve
• Claustrophobia or any other condition, such as psychiatric disorder, that in the opinion of the investigator may prevent the participant from following and completing the protocol

Lab values

• Anaemia with haemoglobin \< 9,0 g/dl
• Systemic infections (CRP \> 1 mg/dl)
• Medications that affect blood glucose levels (e.g. antidiabetics \[except from the subjects forming the diabetes group\], steroids) in the last six months

Other

• BMI \< 18.5 kg/m2
• Pregnancy or breastfeeding
• Inability to follow the study protocol
• Pacemaker
• Metal prosthesis
• Implanted magnetic metal parts
• Spirals
• Fixed metal dental braces
• Acupuncture needle
• Insulin pumps
• By MRI \> 3 Tesla: Tattoos, permanent eyeliner
• Subject dimensions not allowing the performance of MRI

• 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