Status:
RECRUITING
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?
Lead Sponsor:
Norwegian School of Sport Sciences
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Healthy Aging
Age-Related Sarcopenia
Eligibility:
MALE
55-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This project's primary aim of this double-blinded, randomised, placebo-controlled trial is to investigate whether short-term testosterone administration +/- resistance exercise training induces a musc...
Eligibility Criteria
Inclusion
- Sedentary males
- 55-70 years old
- Serum testosterone levels \>8 nmol/L measured in the morning
- Without any known illness, disease or other conditions
- Undergone screening through medical questionnaire, physical examination, routine blood tests and urine sample
- Written informed consent received
Exclusion
- Current or previous participation in a formal exercise regime
- A BMI \< 18 or \> 30 kg·m2
- Hypersensitivity to the study drug or to any of its constituents
- Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100 mmHg), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
- Family history of early (\<55y) death from cardiovascular disease
- Haematocrit \>50%
- Malignancy
- Prostate-specific antigen (PSA) \>4 ng/mL
- Lower urinary tract symptoms
- Taking beta-adrenergic blocking agents, statins, non-steroidal anti-inflammatory drugs
- Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial), epilepsy
- Respiratory diseases including: pulmonary hypertension, chronic obstructive pulmanary disease (COPD), asthma, sleep apnoea
- Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
- Active inflammatory bowel or renal disease
- Current or previous steroid treatment or hormone replacement therapy
- Clotting dysfunction
- Musculoskeletal or neurological disorders
- Alcohol or drug abuse
- Receiving oral anticoagulants
- Serum testosterone levels above the reference range for 50 year olds (\>32 nmol/L) (Bjerner et al., 2009) measured in the morning 1
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05964920
Start Date
September 1 2024
End Date
September 30 2025
Last Update
October 15 2024
Active Locations (1)
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1
Norwegian School of Sport Sciences
Oslo, Norway, 0863