Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
NCT ID: NCT06396871
Last Updated: 2024-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2023-10-16
2026-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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High risk - Liver Fibrosis
1. FIB-4 score ≥ 1.3 AND
2. Fibroscan measurement ≥ 8kPa
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.
Low risk - Liver Fibrosis
Fibroscan measurements \< 8kPa
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.
Steatotic Liver Disease
Diagnosis of steatosis in ultrasound AND CAP \> 275 dB/m
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.
No Steatotic Liver Disease
No steatosis in liver ultrasound AND CAP ≤ 275 dB/m
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.
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 AND/OR history of Diabetes, treated with at least one antidiabetic medication
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.
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
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.
Normal glucose tolerance
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Responsible Party
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Locations
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University Study Center for Metabolic Diseases
Dresden, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BO-EK-508112022
Identifier Type: -
Identifier Source: org_study_id
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