Systemic Hormones and Muscle Protein Synthesis

NCT03054168 | Unknown Phase 3 DMC

• 1 other identifier: Hormones
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of increase in testosterone levels in older males and the effects of decrease in testosterone levels in young males on muscle protein synthesis.

Conditions

Sarcopenia; Muscle Hypotrophy; Muscle Atrophy

Keywords

Protein Synthesis; Hypertrophy; Testosterone

Outcome Measures

Primary Outcomes (1)

• Muscle Protein Synthesis

  Comparison of muscle protein synthesis between young and older individuals when their testosterone levels decrease and increase, respectively; in response to 6 weeks whole body resistance exercise training

  0-6 Weeks

Study Arms (4)

Old Testosterone trained

EXPERIMENTAL

8 old participants (65-75 years old) who will receive resistance exercise training and Testosterone (Sustanon 250: 250 mg every 2wks) Drug name: Sustanon 250 Generic Name: Testosterone Proprietary Name: N/A Formulation: 250mg of Testosterone in 1ml volume Dose: 250mg of testosterone Frequency: every 2 weeks Route: intramuscular injection

Drug: Sustanon 250

Old Placebo trained

PLACEBO COMPARATOR

8 old participants (65-75 years old) who will receive resistance exercise training and Placebo every two weeks.

Other: Placebo

Young Zoladex trained

EXPERIMENTAL

8 young participants (18-30 years old) who will receive resistance exercise training and Testosterone inhibitor (3.6mg Zoladex subcutaneous injection, one time over the study) Drug name: Zoladex Generic Name: Gonadotropin-releasing hormone analogue; Goserelin Proprietary Name: N/A Formulation: Solution for injection Dose: 3.6mg Frequency: Single injection one time over the study. Route: Subcutaneous injection (abdomen) performed by clinician.

Drug: Zoladex

Young placebo trained

PLACEBO COMPARATOR

8 young participants (18-30 years old) who will receive resistance exercise training and placebo, one time over the study.

Other: Placebo

Interventions

Sustanon 250 DRUG

The frequency of the injection will be every 2 weeks, 250mg of testosterone, intramuscular injection.

Also known as: Testosterone

Old Testosterone trained

Zoladex DRUG

The frequency of the injection will be just one injection, 3.6 mg of Zoladex, Subcutaneous injection (abdomen).

Also known as: Gonadotropin-releasing hormone analogue; Goserelin

Young Zoladex trained

Placebo OTHER

Also known as: Saline

Old Placebo trained; Young placebo trained

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: All participants are male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Young (18-30y) and old (60-75y) males who are generally healthy

You may not qualify if:

• Participation in a formal exercise regime
• BMI \< 18 or \> 30 kg·m2
• Active cardiovascular disease:
• uncontrolled hypertension (BP \> 160/100),
• angina,
• heart failure (class III/IV),
• arrhythmia,
• right to left cardiac shunt,
• recent cardiac event
• Taking beta-adrenergic blocking agents, statins, non-steroidal anti-inflammatory drugs or HRT
• Cerebrovascular disease:
• previous stroke,
• aneurysm (large vessel or intracranial)
• epilepsy
• Respiratory disease including:

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital Medical School

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

Related Publications (7)

• Mauras N, Hayes V, Welch S, Rini A, Helgeson K, Dokler M, Veldhuis JD, Urban RJ. Testosterone deficiency in young men: marked alterations in whole body protein kinetics, strength, and adiposity. J Clin Endocrinol Metab. 1998 Jun;83(6):1886-92. doi: 10.1210/jcem.83.6.4892.

  PMID: 9626114 BACKGROUND

• Kvorning T, Andersen M, Brixen K, Madsen K. Suppression of endogenous testosterone production attenuates the response to strength training: a randomized, placebo-controlled, and blinded intervention study. Am J Physiol Endocrinol Metab. 2006 Dec;291(6):E1325-32. doi: 10.1152/ajpendo.00143.2006. Epub 2006 Jul 25.

  PMID: 16868226 BACKGROUND

• Abbasi AA, Drinka PJ, Mattson DE, Rudman D. Low circulating levels of insulin-like growth factors and testosterone in chronically institutionalized elderly men. J Am Geriatr Soc. 1993 Sep;41(9):975-82. doi: 10.1111/j.1532-5415.1993.tb06764.x.

  PMID: 8409184 BACKGROUND

• Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.

  PMID: 11158037 BACKGROUND

• Baker JR, Bemben MG, Anderson MA, Bemben DA. Effects of age on testosterone responses to resistance exercise and musculoskeletal variables in men. J Strength Cond Res. 2006 Nov;20(4):874-81. doi: 10.1519/R-18885.1.

  PMID: 17194250 BACKGROUND

• Kumar V, Selby A, Rankin D, Patel R, Atherton P, Hildebrandt W, Williams J, Smith K, Seynnes O, Hiscock N, Rennie MJ. Age-related differences in the dose-response relationship of muscle protein synthesis to resistance exercise in young and old men. J Physiol. 2009 Jan 15;587(1):211-7. doi: 10.1113/jphysiol.2008.164483. Epub 2008 Nov 10.

  PMID: 19001042 BACKGROUND

• Vingren JL, Kraemer WJ, Ratamess NA, Anderson JM, Volek JS, Maresh CM. Testosterone physiology in resistance exercise and training: the up-stream regulatory elements. Sports Med. 2010 Dec 1;40(12):1037-53. doi: 10.2165/11536910-000000000-00000.

  PMID: 21058750 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Hypertrophy

Interventions

Testosterone; Goserelin; Gonadotropin-Releasing Hormone; Sodium Chloride

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Philip J Atherton, Professor

  The University of Nottingham

  PRINCIPAL INVESTIGATOR

• Nathaniel Szewczyk, Ass. Proff

  The University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Philip Atherton

Model Details: To achieve our aims we will recruit 16 young healthy males (Age: 18-30 y; BMI: 18-30kg/m2) and 16 older healthy males (Age: 65-75 y; BMI: 18-30kg/m2). Volunteers will then be randomly assigned to a testing group; 1) Young placebo trained (N=10), 2) Young gonadotropin releasing hormone analogue trained (3.6mg Zoladex subcutaneous injection (every 4 weeks) N=10), 3) Old placebo trained (N=10) and 4) Old Testosterone trained (Sustanon 250: 250 mg every 2-3wks intramuscular injection, N=10). All participants will receive whole body resistance exercise training for six weeks.

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 15, 2017
• Study Start: December 15, 2016
• Primary Completion: November 15, 2018
• Study Completion: February 15, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

GB (1)