General aim To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery. Objectives To evaluate the effect of testosterone therapy combined with exercise and diet counselling on muscle strength, body composition, hormones, components of the metabolic syndrome, inflammation, sexual function, and quality of life after weight loss in obese, hypogonadal men undergoing bariatric surgery.
Conditions
Interventions
Trade Name: Nebido
Pharmaceutical Form:
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Sponsors
Line Velling Magnussen
Eligibility
Sex/Gender
Male
Inclusion 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) [41] - Caucasian men - Total testosterone =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years. - Symptomatic heart disease NYHA >2 - Recently thromboembolic disease 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.;Secondary Objective: To evaluate the effect of testosterone therapy combined with exercise and diet counselling on muscle strength, body composition, hormones, components of the metabolic syndrome, inflammation, sexual function, and quality of life after weight loss in obese, hypogonadal men undergoing bariatric surgery.;Primary end point(s): Primary outcome: -Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation. ;Timepoint(s) of evaluation of this end point: December 2020 – December 2024 Last-patient-last-visit December 2024 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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) - Adipokines and inflammation markers (leptin, adiponectin, hsCRP, IL-6, suPAR, lipid profile (HDL, LDL, triglycerides)) - Hormones and binding proteins (testosterone, SHBG, LH, FSH, prolactin, CBG, growth hormone-axis (IGF-I and IGF-II, IGFBPs, bioactive IGF-I), cortisol, aldosterone, Cortisol and cortisol metabolites) - Vascular markers (soluble Klotho, fibulin-1) - Bone markers and calcitropic hormones (osteocalcin, PICP, 1CTP, CTX, PTH, 25OH-vitaminD, 1.25(OH)2-Vitamin-D) - Quality of life and sexual function (International Index of Erectile Function (IIEF-5), Profile of Mood States – short form (POMS-sf), Major Depression Inventory (MDI), World Health Organization Well Being Index (WHO-5), Physical function component of Vitality scale of Short Form 36 (SF36);Timepoint(s) of evaluation of this end point: Approximately 2025 | — |
Countries
Denmark
Contacts
Public ContactLine Velling Magnussen
Hospital of Southwest Jutland
Outcome results
None listed