NCT06396871|Recruiting
Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
PERIMED
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PERIMED
Sponsor study identifier
observational
180
1 country
1
Study Start
October 16, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 16, 2023
Actual (reported)December 22, 2023
Actual (reported)May 2, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Qualitative differences in platelets
% of Platelet aggregation
1 day
Quantitative differences in platelets
Platelet count in GPt/L
1 day
Quantitative differences in leukocytes
1 day
Quantitative differences in neutrophils
1 day
Quantitative differences in lymphocytes
1 day
Quantitative differences in monocytes
1 day
Qualitative differences in neutrophils in NETosis
1 day
1. FIB-4 score ≥ 1.3 AND 2. Fibroscan measurement ≥ 8kPa
Fibroscan measurements \< 8kPa
Diagnosis of steatosis in ultrasound AND CAP \> 275 dB/m
75g of a standardized glucose solution followed by blood draw at 0, 30, 60, 90, 120 min
Study population will include subjects belonging to one of the 7 investigation groups. The same subject might belong simultaneously to more than one group (i.e. to fibrosis or no fibrosis group, to steatotic liver disease or no steatotic liver disease group and to normal glucose tolerance, prediabetes or diabetes).
University Study Center for Metabolic Diseases
Dresden, Saxony, 01307, Germany
Plasma, Serum, Peripheral Blood Mononuclear Cells, Neutrophils, DNA
First Submitted
December 22, 2023
First Posted
May 2, 2024
Study Start
October 16, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Multinational Point Prevalence Study on the Management of Diabesity in Hospitals
No steatosis in liver ultrasound AND CAP ≤ 275 dB/m
1. HbA1c ≥ 6.5% OR/AND 2. Fasting Glucose \> 126 mg/dl OR/AND 3. Glucose at 120 min of OGTT \> 200 mg/dl AND/OR history of Diabetes, treated with at least one antidiabetic medication
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
1. HbA1c \< 5.7% AND 2. Fasting glucose \< 100 mg/dl AND 3. Glucose at 120 min of OGTT \<140 mg/dl and no history of Diabetes
A crude assessment of liver status in order to identify the presence of steatosis or not will take place with ultrasound.
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).
The exact calculation of liver fat with proton density fat fraction will take place with MRI.
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Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 2, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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