Trial · Interventional
Status unknownNot applicableRegistry dataDenmark
1 trial
Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle
NCT0387899230 Apr 2019 to est. 31 Dec 2021
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
12 adult hypopituitary patients with newly diagnosed Growth hormone (GH)-deficiency will be studied two times. The first examinations will be performed shortly after time of diagnose before initiation of exogenous GH treatment, where each subject will receive a single intravenous bolus of 0.5 mg GH. The examination day will be repeated after prolonged GH replacement therapy (\>3 month after treatment initiation).
Other
GHD
GHD patients will be studied two times - one time before initiation of GH replacement therapy and one time following three months of GH replacement therapy. The two trial days are identical
Outcomes the sponsor listed as primary.
Phosphorylation of Akt in muscle biopsies
Time frame · Analyses will be performed through study completion, an expected average of 1.5 years
Muscle biopsies will be analysed for phosphorylation of Akt
Satellite cell count
Time frame · Analyses will be performed through study completion, an expected average of 1.5 year
The number of Satellite cells per muscle fiber will be analysed on muscle cross sections from muscle biopsies
Satellite cell proliferation and differentiation in cell culture
Time frame · Analyses will be performed through study completion, an expected average of 1.5 year
Analyses of satellite cells ability to proliferate and differentiate will be performed on cell culture following fluorescent activated cell sorting. Comparison will be between first and second visit.
Strength of muscle
Time frame · Analyses will be performed through study completion, an expected average of 1.5 year
assessed by isokinetic/dynamic measurements using a dynamometer
Muscle mass
Time frame · Analyses will be performed through study completion, an expected average of 1.5 year
Qualified by DXA scan
Glucose turnover rate
Time frame · Analyses will be performed through study completion, an expected average of 1.5 year
Evaluated through blood samples
Fatty acid turn over rate
Time frame · Analyses will be performed through study completion, an expected average of 1.5 year
evaluated through blood samples
Urea turnover rate
Time frame · Analyses will be performed through study completion, an expected average of 1.5 year
evaluated by blood samples and urin collection
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.
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Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 1989
Salomon et al. 1989The New England journal of medicinecited by 770
PMID 2687691DOI 10.1056/nejm198912283212605PUB-02687691
Who could join, as posted.
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