Skip to content

Muscle strength and -mass after bariatric surgery - a possible effect of testosterone replacement therapy? Randomized, placebo-controlled and double-blinded study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517015-73-00
Enrollment
64
Registered
2024-09-20
Start date
2020-12-15
Completion date
2025-11-06
Last updated
2024-09-20

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

Conditions

Adipositas and male hypogonadism

Brief summary

Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.

Detailed description

Regional body composition (DXA scan, BMI, Waist/hip-ratio) - Physical strength: maximal isometric muscle strength in lower extremities (hip extension, hip abduction), muscle strength in upper-extremities (shoulder abduction, shoulder adduction) - Physical function: performance-based measures of physical function (stair climb test) and maximal oxygen uptake (VO2max). - Glucose metabolism (HOMA-R, HbA1c, Fasting-P-Blood glucose) - Coagulation/fibrinolysis status (thrombin generation measures) - Ad

Interventions

DRUGNebido 1000 mg Injektionslösung
DRUGPlacebo oily solution to Testosterone undecanoate oily solution 0.25 g/mL 4 mL in ampoule for intramuscular use (NEBIDO)

Sponsors

Esbjerg Og Grindsted Sygehus
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.

Secondary

MeasureTime frame
Regional body composition (DXA scan, BMI, Waist/hip-ratio) - Physical strength: maximal isometric muscle strength in lower extremities (hip extension, hip abduction), muscle strength in upper-extremities (shoulder abduction, shoulder adduction) - Physical function: performance-based measures of physical function (stair climb test) and maximal oxygen uptake (VO2max). - Glucose metabolism (HOMA-R, HbA1c, Fasting-P-Blood glucose) - Coagulation/fibrinolysis status (thrombin generation measures) - Ad

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026