NCT06396871 Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
| NCT ID | NCT06396871 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technische Universität Dresden |
| Condition | NAFLD |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2023-10-16 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06396871 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06396871 currently recruiting?
Yes, NCT06396871 is actively recruiting participants. Contact the research team at Nikolaos.Perakakis@ukdd.de for enrollment information.
Where is the NCT06396871 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT06396871 clinical trial?
NCT06396871 is sponsored by Technische Universität Dresden. The trial plans to enroll 180 participants.