Characterizing blood cells and factors in metabolic diseases

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

This study looks at the differences in blood cells and other factors in people with metabolic diseases like diabetes and obesity compared to healthy individuals to better understand these conditions.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Technische Universität Dresden (Academic / other)
• Locations: 1 site (Dresden, Saxony)
• Trial ID: NCT06396871 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old with conditions such as diabetes, obesity, or non-alcoholic fatty liver disease.

Not a fit: Patients without metabolic diseases or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of metabolic diseases, potentially enhancing patient outcomes.

How similar studies have performed: While similar studies have explored aspects of metabolic diseases, this specific approach to deep phenotyping is relatively novel.

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

Where this trial is running

Dresden, Saxony

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

Study contacts

• Study coordinator: Nikolaos Perakakis, MD

Conditions NAFLD; Diabetes Mellitus; Obesity