| CTRI Number |
CTRI/2024/06/069304 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Testosterone treatment on fatty liver in Type 2 diabetic men having low testosterone levels. |
|
Scientific Title of Study
|
Effect of Testosterone Therapy on Indices of MASLD in Men With Type 2 Diabetes Mellitus Having Low Testosterone Levels. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amogh S Chappalagavi |
| Designation |
Senior Resident (Academic), Department of Endocrinology. |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha |
| Address |
Room No.3E60, KP20 hostel, Kushabhadra Campus, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9663087458 |
| Fax |
|
| Email |
dramoghsc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sambit Das |
| Designation |
Professor & HOD, Department of Endocrinology. |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha |
| Address |
Department of Endocrinology, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
8093060177 |
| Fax |
|
| Email |
drsambitendocrine@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amogh S Chappalagavi |
| Designation |
Senior Resident(Academic), Department of Endocrinology. |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha |
| Address |
Room no.3E60, KP20 hostel, Kushabhadra campus, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9663087458 |
| Fax |
|
| Email |
dramoghsc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Amogh S Chappalagavi |
| Address |
Room no.3E60, KP20 hostel, Kushabdhadra campus,Kalinga Institute of Medical Sciences, Patia, Bhubaneswar, Odisha, 751024, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sambit Das |
Professor & HOD, Department of Endocrinology, KIMS & PBMH, Patia, Bhubaneswar, Odisha, 751024 |
| Dr Saroj Kanta Sahu |
Assistant Professor, Department of Gastroenterology, KIMS & PBMH, Patia, Bhubaneswar, Odisha, 751024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amogh S Chappalagavi |
Kalinga Institute of Medical Sciences & Pradyumna Bal Memorial Hospital, Bhubaneswar, Odisha |
Room No.140, Department of Endocrinology, KIMS & PBMH, Patia, Bhubaneswar
Khordha
ORISSA |
9663087458
dramoghsc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences |
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 |
| Intervention |
Inj. Testosterone Undecanoate |
Inj. Testosterone Undecanoate 1000 mg deep I.M. at 0,6 weeks, 3 months, 6 months and 9 months along with standard diabetes care. |
| Comparator Agent |
Metformin, Sulfonylureas, DPP-IV inhibitors, SGLT2 inhibitors, insulin. |
Optimal glycemic control using lifestyle modification, dietary intervention and antidiabetic medication according to individual patient profile. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1)T2DM diagnosis;
2)Fasting Total Testosterone concentration of ≤ 12.0 nmol/L (346 ng/dL)
3)Satisfying MASLD diagnostic criteria.
4)Consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Testosterone therapy in the last 5 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the change in CAP score.
(CAP- Controlled Attenuation Parameter, A modality of fibroscan to estimate hepatic steatosis)
|
Baseline
9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the change in non invasive indices of hepatic steatosis (Hepatic Steatosis Index [HSI], Fatty Liver Index [FLI], Triglyceride to HDL-C ratio [THR]) and fibrosis (AST to Platelet Ratio Index [APRI], Fibrosis-4 Index [FIB-4], NAFLD Fibrosis Score[NFS]) |
Baseline
3 months
6 months
9 months |
|
|
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)
|
10/07/2024 |
| 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="2"
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
|
The study is a randomised open label parallel group single centre trial. Selection of study subjects will be done according to the inclusion and exclusion criteria. Total Sample size is 60 which will be divided into two groups; One group (n=30) will receive Inj Testosterone Undecanoate 1000mg deep I.M. at 0, 6 weeks, 3 months, 6 months and 9 months on top of standard diabetes and NAFLD care. Second group (n=30) will receive only standard diabetes and NAFLD care. Both the groups will receive dietary intervention and lifestyle modification by a trained dietician/ diabetes educator. The patients will be followed up at intervals of 3 months, 6 months and 9 months. The primary outcome is to study the change in CAP score at Baseline and at 9 months. (CAP- Controlled Attenuation Parameter, A modality of fibroscan to estimate hepatic steatosis) and secondary outcome is to study the change in non invasive indices of hepatic steatosis (Hepatic Steatosis Index [HSI], Fatty Liver Index [FLI], Triglyceride to HDL-C ratio [THR]) and fibrosis (AST to Platelet Ratio Index [APRI], Fibrosis-4 Index [FIB-4], NAFLD Fibrosis Score[NFS]) at baseline, 3 months, 6 months and 9 months and compare between the two groups. |