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Recruiting NCT06396871

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

— Observational NAFLD Diabetes Mellitus Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral glucose tolerance test, Liver Ultrasound, Fibroscan of the Liver, Magentic Resonance Imaging (MRI) of the liver.
Who it may be relevant to
Registry conditions: NAFLD, Diabetes Mellitus, Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Diagnostic test Oral glucose tolerance test
    75g of a standardized glucose solution followed by blood draw at 0, 30, 60, 90, 120 min
  • Diagnostic test Liver Ultrasound
    A crude assessment of liver status in order to identify the presence of steatosis or not will take place with ultrasound.
  • Diagnostic test 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).
  • Diagnostic test Magentic Resonance Imaging (MRI) of the liver
    The exact calculation of liver fat with proton density fat fraction will take place with MRI.

Primary outcome measures

  • Qualitative differences in platelets [Time frame: 1 day]
  • Quantitative differences in platelets [Time frame: 1 day]
Secondary outcome measures (9)
  • Quantitative differences in leukocytes [Time frame: 1 day]
  • Quantitative differences in neutrophils [Time frame: 1 day]
  • Quantitative differences in lymphocytes [Time frame: 1 day]
  • Quantitative differences in monocytes [Time frame: 1 day]
  • Qualitative differences in neutrophils in NETosis [Time frame: 1 day]
  • Qualitative differences in neutrophils in phagocytosis [Time frame: 1 day]
  • Qualitative differences in monocytes [Time frame: 1 day]
  • Quantitative differences in Interleukin-6 [Time frame: 1 day]
  • Quantitative differences in Interleukin-8 [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

1\. Age > 18 years old

Additional inclusion criteria for case groups:

  • High risk group for significant liver fibrosis

1\. FIB-4 score ≥ 1.3 AND 2. Fibroscan measurement ≥ 8kPa

  • Steatotic Liver Disease group

1\. Diagnosis of steatosis in ultrasound AND CAP > 275 dB/m

  • Prediabetes
  • HbA1c >5.7 AND <6.5% OR/AND
  • Fasting Glucose 100-125 mg/dl OR/AND
  • Glucose at 120 min of OGTT between 140-200 mg/dl
  • 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

  • HbA1c < 5.7% AND
  • Fasting glucose < 100 mg/dl AND
  • Glucose at 120 min of OGTT <140 mg/dl

Exclusion criteria

  • Diabetes mellitus Typ 1
  • BMI < 18.5 kg/m2
  • Transfusion of blood or major bleeding in the last six months
  • Anaemia with haemoglobin < 9,0 g/dl
  • Chronic alcohol or drug abuse
  • 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.)
  • Systemic infections (CRP > 1 mg/dl)
  • Medications that affect blood glucose levels (e.g. antidiabetics \[except from the subjects forming the diabetes group\], steroids) in the last six months
  • Medications that affect coagulation (e.g. anticoagulants and antiplatelet agents) in the last six months
  • Medications that affect immune function (e.g. immunosuppressive drugs) in the last six months
  • Pregnancy or breastfeeding
  • Severe psychic disorders
  • Inability to follow the study protocol
  • Have any medical condition unsuitable for inclusion in the study, in the opinion of the investigator

Additional exclusion criteria for MRI:

  • Pacemaker
  • Artificial heart valve
  • Metal prosthesis
  • Implanted magnetic metal parts
  • Spirals
  • Fixed metal dental braces
  • Acupuncture needle
  • Insulin pumps
  • By MRI > 3 Tesla: Tattoos, permanent eyeliner
  • 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
  • Subject dimensions not allowing the performance of MRI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Germany · 1 center
  • University Study Center for Metabolic Diseases — Dresden

Identifiers

NCT: NCT06396871 · BO-EK-508112022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗