| CTRI Number |
CTRI/2024/01/061346 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Quantification of the enzymes responsible for metabolism in the vesicles secreted by biological cells |
|
Scientific Title of Study
|
Determining the quantitative status of metabolic enzymes in extracellular vesicles |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Dinesh Upadhya |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Molecular Neurosciences Physiology block 2nd floor Kasturba Medical College Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
08202923612 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dinesh Upadhya |
| Designation |
Associate Professor and Co ordinator |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Molecular Neurosciences Physiology block 2nd floor Kasturba Medical College Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
08202923612 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Namita N Kashyap |
| Designation |
PhD scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Molecular Neurosciences Physiology block 2nd floor Kasturba Medical College Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7022820950 |
| Fax |
|
| Email |
namita.kashyap1@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, near Tiger circle, Manipal, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
DST INSPIRE |
| Address |
Department of Science and Technology, Government of India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal Academy of Higher Education |
Madhav Nagar, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinesh Upadhya |
Kasturba Hospital, Manipal |
Department of Endocrinology, Kasturba Hospital, Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA |
8747012060
dinesh.upadhya@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals
Type II diabetic individuals |
|
| ExclusionCriteria |
| Details |
Previous medical history of any neurological, physiological, pathological or respiratory disorders other than that of Type II diabetes
Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study is conducted to understand and correlate the levels of metabolic enzymes in extracellular vesicles with respect to other blood parameters |
Baseline, 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In addition, the analysis might open up diagnostic & therapeutic targets in metabolic disorders |
Baseline, 2 hours |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
10/01/2024 |
| 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 Applicable |
| 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
|
Extracellular vesicles are the nanoparticles secreted from all the cell types in the body. Extensive research is being conducted on extracellular vesicles and their possible applications in various biomedical aspects. The sufficient quantitative data for the composition of metabolic enzymes in EVs is not available. Quantifying them in EVs could pave way for biomarker discoveries and greatly influence the diagnostic and therapeutic fields. |