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

Obesity Clinical Trial

— PERIMED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06396871
• Other study ID #: BO-EK-508112022
• Status: Recruiting
• Start date: October 16, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Technische Universität Dresden
• Contact: Nikolaos Perakakis, MD
• Phone: +4935145813651
• Email: Nikolaos.Perakakis[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Diseases
• NAFLD
• Obesity

Intervention

Diagnostic Test:
• Oral glucose tolerance test
75g of a standardized glucose solution followed by blood draw at 0, 30, 60, 90, 120 min
• Liver Ultrasound
A crude assessment of liver status in order to identify the presence of steatosis or not will take place with ultrasound.
• Fibroscan of the Liver
FibroScan non-invasively measures the stiffness of the liver by capturing and calculating the speed of a shear wave as it travels through the liver (vibration controlled transient elastography).
• Magentic Resonance Imaging (MRI) of the liver
The exact calculation of liver fat with proton density fat fraction will take place with MRI.

Locations

Country	Name	City	State
Germany	University Study Center for Metabolic Diseases	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative differences in platelets	% of Platelet aggregation	1 day
Primary	Quantitative differences in platelets	Platelet count in GPt/L	1 day
Secondary	Quantitative differences in leukocytes	Leucocyte count in GPt/L	1 day
Secondary	Quantitative differences in neutrophils	Neutrophil count in GPt/L	1 day
Secondary	Quantitative differences in lymphocytes	Lymphocyte count in GPt/L	1 day
Secondary	Quantitative differences in monocytes	Monocyte count in GPt/L	1 day
Secondary	Qualitative differences in neutrophils in NETosis	% of neutrophils performing NETosis (FACS analysis)	1 day
Secondary	Qualitative differences in neutrophils in phagocytosis	% of neutrophils performing phagocytosis (FACS analysis)	1 day
Secondary	Qualitative differences in monocytes	% of monocytes performing phagocytosis (FACS analysis)	1 day
Secondary	Quantitative differences in Interleukin-6	Interleukin-6 in pg/ml	1 day
Secondary	Quantitative differences in Interleukin-8	Interleukin-8 in pg/ml	1 day