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Effect of Testosterone treatment on fatty liver in Type 2 diabetic men having low testosterone levels.

Effect of Testosterone Therapy on Indices of MASLD in Men With Type 2 Diabetes Mellitus Having Low Testosterone Levels. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069304
Enrollment
60
Registered
2024-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: 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. Control Intervention1: Me

Sponsors

Dr Amogh S Chappalagavi
Lead Sponsor
Dr Sambit Das
Collaborator
Dr Saroj Kanta Sahu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Testosterone therapy in the last 5 years

Design outcomes

Primary

MeasureTime frame
To study the change in CAP score. (CAP- Controlled Attenuation Parameter, A modality of fibroscan to estimate hepatic steatosis) Timepoint: Baseline 9 months—

Secondary

MeasureTime frame
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])Timepoint: Baseline 3 months 6 months 9 months—

Countries

India

Contacts

Public ContactAmogh S Chappalagavi

Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha

drsambitendocrine@gmail.com8093060177

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026