Does human skeletal muscle possess an epigenetic memory of testosterone

Phase 1

• Conditions: Sarcopenia, Anti-Doping, Healthy aging, Anabolic resistance; Therapeutic area: Phenomena and Processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: CTIS2023-507815-37-00
• Lead Sponsor: orges Idrettshoegskole

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

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 samples, Written informed consent received.

Exclusion Criteria

Current or previous participation in a formal exercise regime., Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial), epilepsy., Respiratory diseases including: pulmonary hypertension, 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., A BMI < 18 or > 30 kg·m2., 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the ability to retrain and enhance muscle size after a period of detraining / testosterone abstinence between earlier short-term testosterone groups and placebo controls.;Secondary Objective: To identify whether human skeletal muscle can remember” an earlier encounter of short-term testosterone administration by myonuclear accretion and permanence and/or the retention of imprinted epigenetic signatures (DNA methylation)., To identify whether receiving short-term testosterone administration will enhance strength and power gains in the retraining period, even after 12 weeks of detraining and testosterone abstinence compared to placebo controls.;Primary end point(s): Mean differences in fat-free mass, muscle size, and muscle fibre types cross-sectional area (CSA) between placebo or testosterone groups +/- resistance training, measured by DEXA, ultrasound, and muscle biopsies .

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Differences in myonuclear accretion and permanence and/or the retainment of imprinted epigenetic signatures (DNA methylation) and corresponding gene expression in skeletal muscle between placebo or testosterone groups +/- resistance training.;Secondary end point(s):Mean differences in strength, velocity and power between placebo and testosterone groups +/- resistance training, measured by with ultrasound, Keiser leg press machine and IMVC using isokinetic dynamometry