Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647095
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease MASLD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification of New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease MASLD in Patients by Blood Plasma Spectroscopy Breath Volatile Organic Compounds Analysis and Serum Bile Acids Analysis
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn if some components of blood or exhaled breath can diagnose people having more fat in their livers than is normal because of their poorer metabolic health for example because of obesity and diabetes The main questions it aims to answer are
1 Can a method find participants with higher liver fat than healthy participants
2 Can a method find participants in which higher liver fat was a cause of liver inflammation or stiffness
Participants will
fast overnight
have a routine blood draw
easily exhale a few times into a special device or a plastic bag and fill in a short dietary questionnaire if they want to participate in a breath test
optionally swallow capsules with an orange peel extract and fish oil before exhaling which can help get better results from breath capsules will be medically safe and approved
1 Can a method find participants with higher liver fat than healthy participants
2 Can a method find participants in which higher liver fat was a cause of liver inflammation or stiffness
Participants will
fast overnight
have a routine blood draw
easily exhale a few times into a special device or a plastic bag and fill in a short dietary questionnaire if they want to participate in a breath test
optionally swallow capsules with an orange peel extract and fish oil before exhaling which can help get better results from breath capsules will be medically safe and approved
Detailed Description:
Patients with MASLD and healthy volunteers will be offered an observational study evaluating the diagnostic role of new experimental non-invasive methods serum bile acids breath VOC and plasmatic spectroscopic patterns assessing the presence and severity of the liver fibrosis and steatosis
First this study aims to differentiate patients with metabolic dysfunction-associated steatotic liver disease MASLD and metabolic dysfunction-associated steatohepatitis MASH from healthy controls or simple steatosis using three experimental methods
Second we aim to stratify patients with MASLD according to the presencegrade of steatosis and fibrosis any significant F2-3 advanced F3 cirrhosis F4 using the same methods
Experimental methods tested in this study include
1 analyzing the fasting spectrum of serum bile acids using liquid chromatography-mass spectrometry
2 analyzing the disease-specific spectroscopy patterns given by vibrational and chiroptical spectroscopy of blood plasma
3 analyzing trace concentrations of volatile organic compounds VOC in exhaled human breath using the Selected ion flow tube mass spectrometry This contains the so-called stress test of monitoring breath VOC d-Limonene and triethylamine after their regulated ingestion in the form of capsules
These parameters may eventually be combined with anthropometric and laboratory parameters such as age or BMI
Clinical examinations blood sampling ultrasound examinations of the liver and liver elastography will be performed as a part of routine care
Blood parameters results may be evaluated retrospectively
About 60-80 participants in total for each method were anticipated For patients who take part in breath tests adequate insurance is to be guaranteed
Statistical processing individual parameters will be evaluated in an exploratory and a validation group or by the PLS-DA algorithm with repeated cross-validation A difference of p005 will be considered a statistically significant change
First this study aims to differentiate patients with metabolic dysfunction-associated steatotic liver disease MASLD and metabolic dysfunction-associated steatohepatitis MASH from healthy controls or simple steatosis using three experimental methods
Second we aim to stratify patients with MASLD according to the presencegrade of steatosis and fibrosis any significant F2-3 advanced F3 cirrhosis F4 using the same methods
Experimental methods tested in this study include
1 analyzing the fasting spectrum of serum bile acids using liquid chromatography-mass spectrometry
2 analyzing the disease-specific spectroscopy patterns given by vibrational and chiroptical spectroscopy of blood plasma
3 analyzing trace concentrations of volatile organic compounds VOC in exhaled human breath using the Selected ion flow tube mass spectrometry This contains the so-called stress test of monitoring breath VOC d-Limonene and triethylamine after their regulated ingestion in the form of capsules
These parameters may eventually be combined with anthropometric and laboratory parameters such as age or BMI
Clinical examinations blood sampling ultrasound examinations of the liver and liver elastography will be performed as a part of routine care
Blood parameters results may be evaluated retrospectively
About 60-80 participants in total for each method were anticipated For patients who take part in breath tests adequate insurance is to be guaranteed
Statistical processing individual parameters will be evaluated in an exploratory and a validation group or by the PLS-DA algorithm with repeated cross-validation A difference of p005 will be considered a statistically significant change
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None