| CTRI Number |
CTRI/2024/08/072729 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral tadalafil and dapagliflozin in diabetic fatty liver patients to examin there role in reducing insulin resistance |
|
Scientific Title of Study
|
COMPARISON OF THE REDUCTION of INSULIN RESISTANCE BY TADALAFIL AND DAPAGLIFLOZIN AS A COMBINATION THERAPY OVER DAPAGLIFLOZIN MONOTHERAPY IN DIABETIC NAFLD PATIENT :A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepankumar T |
| Designation |
Postgraduate,general medicine |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Room number:60 ,General medicine department,srm medical college hospital and research centre , SRM NAGAR , POTHERI , KATTANKULATHUR,CHENGALPATTU
Chennai
TAMIL NADU
603203
India |
| Phone |
8667696992 |
| Fax |
|
| Email |
dt0437@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavan k |
| Designation |
Professor, general medicine department |
| Affiliation |
Srm medical college hospital and research centre |
| Address |
General medicine department,SRM medical college hospital
SRM nagar, Potheri , kattankulatur , Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
9791099185 |
| Fax |
|
| Email |
madhavak1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Deepankumar T |
| Designation |
Postgraduate, general medicine |
| Affiliation |
Srm medical college hospital and research centre |
| Address |
General medicine department,Srm medical college hospital and research Center , srm nagar , Potheri , kattankulatur , chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8667696992 |
| Fax |
|
| Email |
dt0437@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM institute of science and technology
Srm nagar , kattankulatur campus , Chengalpattu district , Tamilnadu , India ,603203 |
|
|
Primary Sponsor
|
| Name |
SRM institute of science and technology |
| Address |
SRM nagar , Potheri ,Kattankulatur , Chengalpattu , Tamilnadu , India , 603203 |
| Type of Sponsor |
Other [Self] |
|
|
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 Madhavan k |
SRM MEDICAL COLLEGE and research centre |
Room no 60, general medicine department,SRM nagar , Potheri , kattankulathur , Chengalpattu , 603203
Chennai
TAMIL NADU |
9791099185
madhavak1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE hospital-students institutional scientific commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab.Dapagliflozin 10mg od x 3 months |
Group B dapagliflozin 10mg tablet once daily for 3 months and there fasting insulin levels , fib 4 score
,The effect of tadalafil in insulin resistance is being compared with dapagliflozin 10mg , were compared |
| Intervention |
Tab.TADALAFIL 10mg od and Tab.dapagliflozin 10mg od for 3 months |
Group A Tablet TADALAFIL 10mg od , tablet dapagliflozin 10mg od for 3 months
End of 3 months fib 4 score and insulin resistance will be calculated |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 DM
Fib 4 score 1.3
USG abdomen showing fatty liver |
|
| ExclusionCriteria |
| Details |
Heart failure patient
CAD on nitrate
Urinary tract infection
Allergic to drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Group A will have more reduction in insulin resistance than group B |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in ALT thereby reduction in fib 4 score |
Three months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/08/2024 |
| 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="1"
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
|
Non-alcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease, affecting approximately one-quarter of the global population, and has become a world public health issue. NAFLD is a clinicopathological syndrome characterized by hepatic steatosis, excluding ethanol and other definite liver damage factors. Recent studies have shown that the development of NAFLD is associated with lipid accumulation, oxidative stress, endoplasmic reticulum stress, and lipotoxicity. Phosphodiesterase-5 (PDE-5) inhibitors are drugs targeting endothelial dysfunction through increased NO-signalling, resulting in relaxation of vascular smooth muscles and vasodilation.This drug class is currently used in the clinic for the treatment of erectile dysfunction, pulmonary hypertension, and lower urinary tract symptoms. studies have also suggested cardio protective effects.Several preclinical and clinical studies have also demonstrated beneficial metabolic effects of PDE-5 inhibitors for manifestations of the metabolic syndrome and also reduce ALT which is a fatty liver marker
Dapagliflozin treatment remarkably suppressed oleic acid (OA)-induced lipid accumulation and TG content in L02 cells through increased FA β-oxidation, as indicated by elevated proliferator-activated receptor-gamma coactivator-1 alpha (PGC-1α) levels and activation of the AMP-activated protein kinase (AMPK)/mammalian target of rapamycin (mTOR) signaling pathway |