Characterizing blood cells and factors in metabolic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to deeply characterize the differences in peripheral blood cells and circulating factors among patients with metabolic diseases such as diabetes, obesity, and non-alcoholic fatty liver disease compared to healthy controls. It will assess both quantitative and qualitative aspects of platelets and leukocytes, as well as various circulating molecules. The study employs several diagnostic interventions, including oral glucose tolerance tests, liver ultrasounds, and MRI of the liver, to gather comprehensive data on these conditions.

Why it matters

Who can join: the full rules

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 exclusion criteria for MRI:
   1. Pacemaker
   2. Artificial heart valve
   3. Metal prosthesis
   4. Implanted magnetic metal parts
   5. Spirals
   6. Fixed metal dental braces
   7. Acupuncture needle
   8. Insulin pumps
   9. By MRI \> 3 Tesla: Tattoos, permanent eyeliner
   10. 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
   11. Subject dimensions not allowing the performance of MRI

Where it's running

• University Study Center for Metabolic Diseases
  Dresden, Saxony, Germany Recruiting

Study contacts

• Study coordinator: Nikolaos Perakakis, MD
• Email: Nikolaos.Perakakis@ukdd.de
• Phone: +4935145813651

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.