E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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E.1.1.1 | Medical condition in easily understood language |
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Kan man bibeholde muskelmassen og muskelstyrken under et vægttab foranlediget af gastric bypass ved at behandle mænd med nedsat testosteron i blodet med testosteron og livsstilsændringer |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 12.0 nmol/l - No contraindications for testosterone treatment
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E.4 | Principal 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 <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%
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome: - Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
December 2020 – December 2024 Last-patient-last-visit December 2024 |
Inklusion af første projektdeltager d. 15. december 2020. Vi har forventet slutdato (last-patient-last-visit) i december 2024. |
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E.5.2 | 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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |