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

Phase 4

Active, not recruiting

• Conditions: Adipositas and male hypogonadism

• Registration Number: 2024-517015-73-00
• Lead Sponsor: Esbjerg Og Grindsted Sygehus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-20
• Last Update Posted: 2024-09-20

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Male
• Target Recruitment: 64

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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		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

Trial Locations

Locations (1)

Esbjerg Og Grindsted Sygehus; 🇩🇰 Esbjerg, Denmark

Esbjerg Og Grindsted Sygehus

🇩🇰Esbjerg, Denmark

Line Velling Magnussen

Site contact

29787835

line.velling.magnussen@rsyd.dk