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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02243852 |
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Date of registration:
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16/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)
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Scientific title:
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Evaluation of the Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) Concentration in Patients With Growth Hormone Deficiency (GHD) |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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48 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02243852 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Daniel J Cuthbertson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Liverpool |
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Name:
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Daniel J Cuthbertson, PhD |
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Address:
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Telephone:
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+441515295911 |
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Email:
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daniel.cuthbertson@liverpool.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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All evaluations to determine eligibility into the study and for growth hormone replacement
are performed as part of routine clinical care. It should be emphasised that no research
specific screening tests will be performed. Patients deemed eligible for entry into study,
who decline to participate in the research, will still be commenced on growth hormone in
line routine clinical care.
Inclusion criteria: Patients with confirmed GH deficiency who are deemed eligible for GH
replacement as assessed by the AGHDA QOL questionnaire.
Exclusion criteria: Claustrophobia or having significant metal work is a contra-indication
to MRI scanning.
Withdrawal criteria: Patients will be withdrawn from the study if they discontinue their
growth hormone replacement therapy for any clinical reason.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Growth Hormone Replacement Therapy
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Primary Outcome(s)
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FGF21
[Time Frame: 6-months]
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Secondary Outcome(s)
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Visceral and subcutaneous fat
[Time Frame: 6-months]
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Secondary ID(s)
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13/NW/0075
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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