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

Last updated: April 29, 2024
Sponsor: Technische Universität Dresden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Metabolic Disorders

Diabetes Prevention

Treatment

Liver Ultrasound

Oral glucose tolerance test

Fibroscan of the Liver

Clinical Study ID

NCT06396871
BO-EK-508112022
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Age > 18 years old Additional inclusion criteria for case groups:
  2. High risk group for significant liver fibrosis
  3. FIB-4 score ≥ 1.3 AND 2. Fibroscan measurement ≥ 8kPa
  4. Steatotic Liver Disease group
  5. Diagnosis of steatosis in ultrasound AND CAP > 275 dB/m
  6. Prediabetes
  7. HbA1c >5.7 AND <6.5% OR/AND
  8. Fasting Glucose 100-125 mg/dl OR/AND
  9. Glucose at 120 min of OGTT between 140-200 mg/dl
  10. 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 casegroup, 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#) Nosteatosis group
  11. No steatosis in liver ultrasound AND CAP ≤ 275 dB/m C#) Normal glucose tolerancetest group
  12. HbA1c < 5.7% AND
  13. Fasting glucose < 100 mg/dl AND
  14. Glucose at 120 min of OGTT <140 mg/dl

Exclusion

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 fattyliver 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 thesubjects 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 thelast 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 opinionof the investigator Additional exclusion criteria for MRI:
  15. Pacemaker
  16. Artificial heart valve
  17. Metal prosthesis
  18. Implanted magnetic metal parts
  19. Spirals
  20. Fixed metal dental braces
  21. Acupuncture needle
  22. Insulin pumps
  23. By MRI > 3 Tesla: Tattoos, permanent eyeliner
  24. Claustrophobia or any other condition, such as psychiatric disorder, that in theopinion of the investigator may prevent the participant from following andcompleting the protocol
  25. Subject dimensions not allowing the performance of MRI

Study Design

Total Participants: 180
Treatment Group(s): 4
Primary Treatment: Liver Ultrasound
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University Study Center for Metabolic Diseases

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

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