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Trial · Interventional

Status unknownPhase 3Registry data

Systemic Hormones and Muscle Protein Synthesis

NCTNCT03054168 (opens ClinicalTrials.gov in a new tab)Other idHormones
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
34 participants (actual)
Sponsor
University of Nottingham · Other
Design
Randomized · Triple masking
Countries
1 country

United Kingdom

Start
15 Dec 2016
Primary completion
15 Nov 2018
Completion
15 Feb 2019 (estimated)
First posted
15 Feb 2017
Last update posted
26 Feb 2019
Conditions
Sarcopenia · Muscle Hypotrophy · Muscle Atrophy

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 3

    Systemic Hormones and Muscle Protein Synthesis

    NCT03054168

    15 Dec 2016 to est. 15 Feb 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Sustanon 250Drug
  • ZoladexDrug
  • PlaceboOther

Arms4

  • Experimental

    Old Testosterone trained

    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

  • Placebo comparator

    Old Placebo trained

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

  • Experimental

    Young Zoladex trained

    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.

  • Placebo comparator

    Young placebo trained

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Muscle Protein Synthesis

    Time frame · 0-6 Weeks

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2006

4 results

Suppression of endogenous testosterone production attenuates the response to strength training: a randomized, placebo-controlled, and blinded intervention study.

Kvorning et al. 2006American journal of physiology. Endocrinology and metabolismcited by 118

PMID 16868226DOI 10.1152/ajpendo.00143.2006PUB-16868226

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

1 study on this page

PubMed tag: none · 1998

Testosterone deficiency in young men: marked alterations in whole body protein kinetics, strength, and adiposity.

Mauras et al. 1998The Journal of clinical endocrinology and metabolismcited by 255

PMID 9626114DOI 10.1210/jcem.83.6.4892PUB-09626114

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Young (18-30y) and old (60-75y) males who are generally healthy Exclusion Criteria: * 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: * pulmonary hypertension, * COPD, * asthma, * Metabolic disease: * hyper and hypo parathyroidism, * Hypo and hyper gonadism * untreated hyper and hypothyroidism, * Cushing's disease, * type 1 or 2 diabetes * Active inflammatory bowel or renal disease * Malignancy * Altered hormonal profile * Recent steroid treatment (within 6 months) or hormone replacement therapy * Clotting dysfunction * Musculoskeletal or neurological disorders * Family history of early (\<55y) death from cardiovascular disease

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