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

Launched by TECHNISCHE UNIVERSITÄT DRESDEN · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how certain blood cells and substances in the body differ in people with metabolic diseases like diabetes, obesity, and non-alcoholic fatty liver disease (NAFLD) compared to healthy individuals. Researchers want to understand the differences in both the number and characteristics of specific blood cells, such as platelets and white blood cells, as well as other important molecules in the blood. By studying these differences, the trial aims to uncover more about how these diseases work and potentially improve treatments in the future.

To participate in this study, individuals must be over 18 years old and may need to meet certain health criteria, such as being at high risk for liver disease or having conditions like prediabetes or diabetes. Participants can expect to provide blood samples and undergo some tests to help researchers gather necessary information. It's important to note that certain health conditions and medications could exclude someone from joining the trial, so potential participants should discuss their health history with the study team.

Gender

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Eligibility criteria

• 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