| CTRI Number |
CTRI/2025/06/089163 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the role of altered mitochondrial function in Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Elucidating the role of altered mitochondrial function and inflammatory signaling in insulin
resistance to Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MAHE/ RG0124050I dated 02/04/2024 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranita Ghosh Dastidar |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Biochemistry department and Center for Emerging and Tropical Diseases (CETD), KMC, Manipal
3rd Floor, MIV Building, Madhava Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8088652524 |
| Fax |
|
| Email |
ranita.gd@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranita Ghosh Dastidar |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Biochemistry department and Center for Emerging and Tropical Diseases (CETD), KMC, Manipal
3rd Floor, MIV Building, Madhava Nagar
KARNATAKA
576104
India |
| Phone |
8088652524 |
| Fax |
|
| Email |
ranita.gd@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranita Ghosh Dastidar |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Biochemistry department and Center for Emerging and Tropical Diseases (CETD), KMC, Manipal
3rd Floor, MIV Building, Madhava Nagar
KARNATAKA
576104
India |
| Phone |
8088652524 |
| Fax |
|
| Email |
ranita.gd@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Intramural Fund from Manipal Academy of Higher Education (MAHE), Manipal 576104, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Intramural Fund from Manipal Academy of Higher Education (MAHE) |
| Address |
Advanced Research Centre, Directorate of Research, Ground floor, Madhav Nagar, MAHE, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Deemed to be University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ranita Ghosh Dastidar |
KMC, Manipal and Kasturba Hospital |
Biochemistry department and Center for Emerging and Tropical Diseases (CETD), KMC, Manipal
3rd Floor, MIV Building, Madhava Nagar
Udupi
KARNATAKA |
08088652524
ranita.gd@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E168||Other specified disorders of pancreatic internal secretion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Men between 40 to 45yrs of age.
2. No history of diabetes mellitus (HbA1C less than or equal to 5.7%)
3.No major co-morbidity
4. Individuals with no history of tobacco/nicotine usage for past 3 months from the point of recruitment for
the study.
5. Individuals with no history of consumption of alternative medicines for 3 months from the point of recruitment (Ayurverda, Homeopathy, Siddha, Naturopathy, Unani etc.)
6. Individuals screened and cleared for the following parameters: fasting and post prandial glucose, fasting insulin, CRP, Lipid profile, Plasma lactate, HbA1C.
7. Individuals with no evidence of any active infection or chronic disease. |
|
| ExclusionCriteria |
| Details |
1.Individuals under 40yrs and above 45yrs of age.
2.Individuals with the history of comorbidity.
3.Individuals with history of smoking / nicotine usage / consumption of alternative medicine/ dietary changes as per alternative medicine.
4.Women recruits are excluded from the study.
5.Individuals who have undergone any surgical procedures within the past three months prior to recruitment will be excluded from participation in the study.
6.Individuals who are obese-BMI more than 30. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Altered biochemical parameters can be expected in T2DM patients. |
Baseline i.e. 0th time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understanding the relationship between mitochondrial dysfunction & innate immune responses to IR in T2DM patients. |
Baseline i.e. 0th time point |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
27/06/2025 |
| 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 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
|
Our studies will help us understand the relationship between mitochondrial dysfunction and innate immune responses to insulin resistance in T2DM patients which could lay foundation for further temporal studies focusing on the compensated innate immune responses in T2DM thereby, opening new approaches in the management of hyperglycemia, improved insulin sensitivity and delay the on-set of secondary complications of T2DM. |