NAFLDPERIMEDNCT06396871
Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
An observational study of NAFLD and Diabetes Mellitus, run by Technische Universität Dresden at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, Diabetes Mellitus, Obesity
- What is being tested?
- Oral glucose tolerance test, Liver Ultrasound and Fibroscan of the Liver
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
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- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Study Center for Metabolic Diseases
Dresden, Saxony, 01307
Nikolaos Perakakis, MD, +49 351 458 13651, Nikolaos.Perakakis@ukdd.de
Ingo Weigmann, MD, +49 351 458 11723, Ingo.Weigmann@ukdd.de
About this study
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
- Conditions
- NAFLD, Diabetes Mellitus, Obesity
- Being tested
- Oral glucose tolerance test, Liver Ultrasound, Fibroscan of the Liver, Magentic Resonance Imaging (MRI) of the liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testDiagnostic test
75g of a standardized glucose solution followed by blood draw at 0, 30, 60, 90, 120 min
Liver UltrasoundDiagnostic test
A crude assessment of liver status in order to identify the presence of steatosis or not will take place with ultrasound.
Fibroscan of the LiverDiagnostic test
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 liverDiagnostic test
The exact calculation of liver fat with proton density fat fraction will take place with MRI.
| Study group | Role | What they receive |
|---|---|---|
| High risk - Liver Fibrosis | 1. FIB-4 score ≥ 1.3 AND
2. Fibroscan measurement ≥ 8kPa Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Liver Ultrasound; Diagnostic Test: Fibroscan of the Liver; Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver | |
| Low risk - Liver Fibrosis | Fibroscan measurements < 8kPa Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Liver Ultrasound; Diagnostic Test: Fibroscan of the Liver; Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver | |
| Steatotic Liver Disease | Diagnosis of steatosis in ultrasound AND CAP > 275 dB/m Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Liver Ultrasound; Diagnostic Test: Fibroscan of the Liver; Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver | |
| No Steatotic Liver Disease | No steatosis in liver ultrasound AND CAP ≤ 275 dB/m Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Liver Ultrasound; Diagnostic Test: Fibroscan of the Liver; Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver | |
| 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 Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Liver Ultrasound; Diagnostic Test: Fibroscan of the Liver; Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver | |
| 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 Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Liver Ultrasound; Diagnostic Test: Fibroscan of the Liver; Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver | |
| 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 Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Liver Ultrasound; Diagnostic Test: Fibroscan of the Liver; Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative differences in platelets
% of Platelet aggregation
Measured: 1 day
Quantitative differences in platelets
Platelet count in GPt/L
Measured: 1 day
Secondary outcomes (9)
Quantitative differences in leukocytes
Leucocyte count in GPt/L
Measured: 1 day
Quantitative differences in neutrophils
Neutrophil count in GPt/L
Measured: 1 day
Quantitative differences in lymphocytes
Lymphocyte count in GPt/L
Measured: 1 day
Quantitative differences in monocytes
Monocyte count in GPt/L
Measured: 1 day
Qualitative differences in neutrophils in NETosis
% of neutrophils performing NETosis (FACS analysis)
Measured: 1 day
Qualitative differences in neutrophils in phagocytosis
% of neutrophils performing phagocytosis (FACS analysis)
Measured: 1 day
Qualitative differences in monocytes
% of monocytes performing phagocytosis (FACS analysis)
Measured: 1 day
Quantitative differences in Interleukin-6
Interleukin-6 in pg/ml
Measured: 1 day
Quantitative differences in Interleukin-8
Interleukin-8 in pg/ml
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start16 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396871
- Sponsor's protocol ID
- BO-EK-508112022
- Acronym
- PERIMED
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2023
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD and biospecimens in pseudonymized form might be shared with other researchers upon written request.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases
- ClinicalTrials.gov ID
- NCT06396871
- Acronym / sponsor ID
- PERIMED / BO-EK-508112022
- Conditions
- NAFLD, Diabetes Mellitus, Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| High risk - Liver Fibrosis | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Liver Ultrasound, Diagnostic Test: Fibroscan of the Liver, Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver1. FIB-4 score ≥ 1.3 AND 2. Fibroscan measurement ≥ 8kPa |
| Low risk - Liver Fibrosis | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Liver Ultrasound, Diagnostic Test: Fibroscan of the Liver, Diagnostic Test: Magentic Resonance Imaging (MRI) of the liverFibroscan measurements < 8kPa |
| Steatotic Liver Disease | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Liver Ultrasound, Diagnostic Test: Fibroscan of the Liver, Diagnostic Test: Magentic Resonance Imaging (MRI) of the liverDiagnosis of steatosis in ultrasound AND CAP > 275 dB/m |
| No Steatotic Liver Disease | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Liver Ultrasound, Diagnostic Test: Fibroscan of the Liver, Diagnostic Test: Magentic Resonance Imaging (MRI) of the liverNo steatosis in liver ultrasound AND CAP ≤ 275 dB/m |
| Diabetes | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Liver Ultrasound, Diagnostic Test: Fibroscan of the Liver, Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver1. 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 |
| Prediabetes | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Liver Ultrasound, Diagnostic Test: Fibroscan of the Liver, Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver1. 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 |
| Normal glucose tolerance | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Liver Ultrasound, Diagnostic Test: Fibroscan of the Liver, Diagnostic Test: Magentic Resonance Imaging (MRI) of the liver1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (17 listed)
- 1. Age > 18 years old
- 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
Key exclusion criteria (26 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance test75g of a standardized glucose solution followed by blood draw at 0, 30, 60, 90, 120 min | Diagnostic test | Diabetes, High risk - Liver Fibrosis, Low risk - Liver Fibrosis, No Steatotic Liver Disease, Normal glucose tolerance, Prediabetes, Steatotic Liver Disease |
| Liver UltrasoundA crude assessment of liver status in order to identify the presence of steatosis or not will take place with ultrasound. | Diagnostic test | Diabetes, High risk - Liver Fibrosis, Low risk - Liver Fibrosis, No Steatotic Liver Disease, Normal glucose tolerance, Prediabetes, Steatotic Liver Disease |
| Fibroscan of the LiverFibroScan 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 | Diabetes, High risk - Liver Fibrosis, Low risk - Liver Fibrosis, No Steatotic Liver Disease, Normal glucose tolerance, Prediabetes, Steatotic Liver Disease |
| Magentic Resonance Imaging (MRI) of the liverThe exact calculation of liver fat with proton density fat fraction will take place with MRI. | Diagnostic test | Diabetes, High risk - Liver Fibrosis, Low risk - Liver Fibrosis, No Steatotic Liver Disease, Normal glucose tolerance, Prediabetes, Steatotic Liver Disease |
Primary outcome
Qualitative differences in platelets
Time frame: 1 day
% of Platelet aggregation
Quantitative differences in platelets
Time frame: 1 day
Platelet count in GPt/L
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Undecided. IPD and biospecimens in pseudonymized form might be shared with other researchers upon written request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and Diabetes Mellitus, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos Perakakis, MD (+4935145813651, Nikolaos.Perakakis@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative differences in platelets (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.