Short term recombinant human Growth Hormone administration increases strength and power, but does it improve sporting performance in anabolic-androgenic steroid users?

ISRCTN ISRCTN13681882
DOI https://doi.org/10.1186/ISRCTN13681882
Secondary identifying numbers 280361999
Submission date
19/10/2006
Registration date
27/10/2006
Last edited
29/06/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Graham
Scientific

1 Lantwit Road
Treforrest
Cardiff
CF37 1DL
United Kingdom

Study information

Study designDouble blind experimental trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleShort term recombinant human Growth Hormone administration increases strength and power, but does it improve sporting performance in anabolic-androgenic steroid users?
Study acronymrhGH on performance
Study objectivesShort-term recombinant human Growth Hormone (rhGH) administration increases strength, power and endurance performance in healthy, abstinent Anabolic-Androgenic Steroid (AAS) using weight lifters.
Ethics approval(s)University of Glamorgan ethics committee. Originally approved on the 22nd January 2002 (ref: SEC3), amended and final approval was granted on the 20th November 2002 (ref: SEC7).
Health condition(s) or problem(s) studiedAnabolic-Androgenic Steroid (AAS) users
InterventionAll physiological tests were performed in the same order for both the experimental group and the controls. Subjects were familiarised with testing procedures. Subjects were examined daily over a period of six weeks between the hours of 09:00 and 11:00 and were anonymous to each other.

Subjects were administered rhGH, under supervision, by subcutaneous abdominal injection, in a controlled hygienic environment, for six consecutive days in a dosage of 0.058 International Units (IU)/kg/day (0.019 mg/kg/day). Subjects were examined prior to the commencement of rhGH administration (day one), one day after six days administration (day seven), and eight days after cessation (day 14). Dietary intake was strictly monitored, using a fourteen day dietary recall.

The control group were an exercise control group and did not take an active substance.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Recombinant human Growth Hormone
Primary outcome measureIncreased strength, power and endurance performance indices.
Secondary outcome measures1. Reduced body fat
2. Increased fat free mass
3. Increased heart rate
Overall study start date01/08/2004
Completion date01/10/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants48
Key inclusion criteriaHealthy individual weight lifters, who were previous experienced users of AAS, in a 12 week abstinent phase
Key exclusion criteriaPositive urinalysis for ergogenic aids
Date of first enrolment01/08/2004
Date of final enrolment01/10/2004

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

University of Glamorgan
1 Lantwit Road
Treforrest
Cardiff
CF37 1DL
United Kingdom

Sponsor information

University of Glamorgan
University/education

1 Lantwit Road
Treforrest
Cardiff
CF37 1DL
Wales
United Kingdom

Website http://www.glam.ac.uk/
ROR logo "ROR" https://ror.org/02mzn7s88

Funders

Funder type

University/education

University of Glamorgan (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2007 Yes No

Editorial Notes

29/06/2016: Publication reference added