CTRI

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CTRI Number

CTRI/2025/03/081653 [Registered on: 05/03/2025] Trial Registered Prospectively

Last Modified On:

07/02/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Case Control Study

Study Design

Other

Public Title of Study

Analysis of blood components in metabolism-related liver diseases.

Scientific Title of Study

Metabolomic Profiling of Extracellular Vesicles in Metabolic dysfunction Associated Steatotic Liver Disease (MASLD)Spectrum

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Swasthika
Designation	PhD Scholar
Affiliation	Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education
Address	Department of Biochemistry, Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education,Manipal Udupi KARNATAKA 576104 India
Phone	9353947048
Fax
Email	gurjarswasthika@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Revathi P Shenoy
Designation	Associate Professor
Affiliation	Department of Biochemistry, Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education,Manipal
Address	Department of Biochemistry, Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education,Manipal Udupi KARNATAKA 576104 India
Phone	9449367734
Fax
Email	karshenoy@gmail.com

Details of Contact Person
Public Query

Name	Dr Athish Shetty
Designation	Associate Professor
Affiliation	Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education
Address	Department of Gastroenterology, Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education,Manipal Udupi KARNATAKA 576104 India
Phone	9901184645
Fax
Email	athish.shetty@manipal.edu

Source of Monetary or Material Support

Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal-576104, Karnataka, India.

Manipal Academy of Higher Education, Manipal-576104, Karnataka, India.

Primary Sponsor

Name	MAHE-IMF
Address	Manipal Academy of Higher Education, Manipal-576104,India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Athish Shetty	Kasturba Medical College	Department of Gastroenterology, Kasturba Medical College, Manipal Udupi KARNATAKA	9901184645 athish.shetty@manipal.edu
Dr Revathi P Shenoy	Kasturba Medical College	Clinical Laboratory and Research Laboratory Department of Biochemistry Kasturba Medical College(KMC), Manipal. Udupi KARNATAKA	9449367734 revathi.shenoy@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K760\|\|Fatty (change of) liver, not elsewhere classified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	For CASE group,the inclusion criteria is as follows (1)The presence of hepatic steatosis identified by imaging techniques or biochemical tests (Liver function tests) or clinical evidence or both, or by biopsy alone, with the presence of at least one of the five cardiometabolic criteria with no other identifiable causes (According to the guidelines of AASLD, 2023). Cardiometabolic criteria include the following: Body Mass Index greater than or equal to 25 kilograms per square meter (23 for Asia) or Waist Circumference greater than 94 centimeters for males and greater than 80 centimeters for females or ethnicity adjusted. Fasting serum glucose greater than or equal to 5.6 millimoles per liter (100 milligrams per deciliter) or two-hour post-load glucose levels greater than or equal to 7.8 millimoles per liter (greater than or equal to 140 milligrams per deciliter) or Hemoglobin A1c greater than or equal to 5.7 percent (39 millimoles per mole) or type 2 diabetes or treatment for type 2 diabetes. Blood pressure greater than or equal to 130 over 85 millimeters of mercury or specific antihypertensive drug treatment. Plasma triglycerides greater than or equal to 1.70 millimoles per liter (150 milligrams per deciliter) or lipid-lowering treatment. Plasma High-Density Lipoprotein cholesterol less than or equal to 1.0 millimole per liter (40 milligrams per deciliter) for males and less than or equal to 1.3 millimoles per liter (50 milligrams per deciliter) for females or lipid-lowering treatment. (2)Patients must be aged 18 years or older at the time of consent. For CONTROL group,the inclusion criteria is as follows (1)Individuals without hepatic steatosis identified either by biochemical tests or clinical evidences, imaging techniques, or by biopsy alone with absence of cardiometabolic criteria with no other identifiable causes (2)Age 18 years or older at the time of consent.

ExclusionCriteria

Details

For the CASE group the exclusion criteria are as follows
(1)Absence of clearly observable cardiometabolic risk factors
(2)History of excess alcohol consumption
(3)Diagnosis of drug-induced liver injury
(4)Patients less than 18 years old at the time of consent
(5)Pregnant and lactating women

For the CONTROL group the exclusion criteria are as follows
(1)History of liver disease, including NAFLD or MASLD.
(2)History of excessive alcohol consumption
(3)Presence of drug-induced liver injury.
(4)Age less than 18 years at the time of consent.
(5)Pregnant or lactating women.

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
Role of extracellular vesicles in MASLD through comparative metabolomic profiling	The primary outcome will be measured every 4 weeks for available samples till the completion of the study.

Secondary Outcome

Outcome	TimePoints
Differentially expressed metabolites in MASLD	The secondary outcome will be measured every six cycles of the primary outcome for the available samples until the completion of the study.

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

10/03/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This study is a diagnostic observational case-cohort study investigating the role of extracellular vesicles in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) through metabolomic profiling and the identification of differentially expressed metabolites. It will include patients aged 18 years or older with hepatic steatosis diagnosed via imaging, biochemical tests, clinical evidence, or biopsy, along with at least one cardiometabolic criterion. The primary outcome measure will be the characterization of extracellular vesicle-associated metabolites and their potential role in MASLD pathophysiology. Secondary outcomes will include the identification of key differentially expressed metabolites and their correlation with disease severity and progression.