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

Esbjerg Og Grindsted Sygehus1 site in 1 country64 target enrollmentSeptember 20, 2024

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

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Esbjerg Og Grindsted Sygehus
Enrollment: 64
Locations: 1
Primary Endpoint: Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.

Registry

euclinicaltrials.eu

Start Date

September 20, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Esbjerg Og Grindsted Sygehus

Responsible Party

Principal Investigator

Line Velling Magnussen

Scientific

Esbjerg Og Grindsted Sygehus

Eligibility Criteria

Inclusion Criteria

•Eligible for bariatric surgery according to the Danish national criteria (i.e. aged 18‒60 years, BMI >35 kg/m2 with specific secondary disease or BMI >40 kg/m2 with significant health issues assessed by the multidisciplinary bariatric team) - Caucasian men - Total testosterone < 12.0 nmol/l - No contraindications for testosterone treatment

Exclusion Criteria

•Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years. - Hypersensitivity to the active substance or to any of the excipients in Nebido® - Symptomatic heart disease NYHA >2 - Recently thromboembolic disease <3 months - PSA >4.0 ug/l or PSA>3.0 ug/l and lower urinary tract symptoms - Disability that severely affect the ability to perform exercise training - EVF > 52% - The following treatments are not allowed in the study:5-α-reductase inhibitors and Prednisolone >5mg/day

Outcomes

Primary Outcomes

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

Secondary Outcomes

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