| CTRI Number |
CTRI/2025/04/084686 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Dapagliflozin on muscle parameters in elderly patients with diabetes mellitus |
|
Scientific Title of Study
|
Effect of SGLT2 inhibitor Dapagliflozin on muscle strength and function in elderly patients with diabetes mellitus |
| 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 VK Sashindran |
| Designation |
Professor of General Medicine |
| Affiliation |
K.S.Hegde Medical College |
| Address |
Department of General Medicine
K.S. Hegde Medical Academy
Nityananda nagar
Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9958826493 |
| Fax |
|
| Email |
vksashindran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VK Sashindran |
| Designation |
Professor of General Medicine |
| Affiliation |
K.S.Hegde Medical College |
| Address |
Department of General Medicine
K.S. Hegde Medical Academy
Nityananda nagar
Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9958826493 |
| Fax |
|
| Email |
vksashindran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VK Sashindran |
| Designation |
Professor of General Medicine |
| Affiliation |
K.S.Hegde Medical College |
| Address |
Department of General Medicine
K.S. Hegde Medical Academy
Nityananda nagar
Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9958826493 |
| Fax |
|
| Email |
vksashindran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nitte University, K.S Hegde Medical Academy, Deralakatte, Mangalore, Karnataka state, India - 575018 |
|
|
Primary Sponsor
|
| Name |
Nitte University |
| Address |
Nitte University, K.S Hegde Medical Academy, Deralakatte, Mangalore, Karnataka State, India - 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 Akhila Bhandarkar |
Room Number 78, basement 2, Endocrinology division,K.S Hegde Medical Academy |
Room Number 78, basement 2, Endocrinology division, K.S Hegde Medical Academy, Nityananda Nagar, Deralakatte, Mangalore, Karnataka, India Pin 575018
Dakshina Kannada
KARNATAKA |
9971508069
drakhila.bhandarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Dapagliflozin tablet |
Baseline muscle parameters will be noted. 10mg od oral tablet Dapagliflozin shall be introduced as a standard of care therapy to patients with diabetes as per inclusion criteria. They will be recalled after 8weeks to recheck the muscle parameters. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients with type 2 diabetes with age above 60 years irrespective of diabetes duration and HbA1C below 8
|
|
| ExclusionCriteria |
| Details |
Already on SGLT2 inhibitors or insulin therapy,Established CKD/CVA/CAD/CLD,Immobility/restricted mobility due to any reason, Intake of drugs -steroids including anabolic ones, oestrogen, testosterone.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in muscle strength and muscle function |
Following oral dapagliflozin 10mg therapy for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Glycemic change with dapagliflozin and its effect on muscle strength and muscle function |
change over 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study is planned to evaluate the effect of SGLT2 inhibitor (Dapagliflozin) on muscle strength and function over a short-term use of 8weeks. Type 2 diabetes patients aged 60 and above will be recruited if their hBA1C is below 8 and not on insulin or SGLT2inhibitor therapy. Patients with other comorbidities with significant effect on muscle strength/function shall be excluded.Following recruitment their muscle strength and function are assessed with simple bedside tests. The, tablet dapagliflozin 10mg (generic) shall be introduced as a part of standard of care therapy. Patients shall be recalled at week 4 for general assessment and note for adverse events if any. At week 8, the same baseline tests for muscle strength and function shall be reperformed and changes if any, noted. |