Charactertizing Growth Hormone Deficiency in Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Calgary
About this trial
The goal of this observational study is to characterize the impact of growth hormone deficiency (GHD) on quality of life, symptom burden, and sleep in adults with traumatic brain injury (TBI), and to evaluate whether these outcomes improve with growth hormone replacement therapy.
The main questions it aims to answer are:
* Does quality of life, as measured by the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), differ between adults with TBI and GHD compared to those with TBI and no GHD? * Do fatigue, cognition, mood, post-concussion symptoms, body image, libido, perceived stress, and sleep architecture differ between these two groups? * Among participants with GHD who begin growth hormone replacement therapy, do symptom burden and quality of life improve over a 12-week treatment period?
Eligible participants will be asked to complete baseline questionnaires and undergo testing for growth hormone deficiency (glucagon stimulation testing). A subset of participants will also complete objective sleep assessments using actigraphy and at-home polysomnography. For those who are diagnosed with growth hormone deficiency and choose to pursue treatment, questionnaires will be repeated bi-weekly while receiving growth hormone replacement therap
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients who have sustained a traumatic brain injury and have persisting symptoms lasting beyond 1 year post-injury.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not applicable (observational study)
Other interventionNot applicable (observational study)
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Suspected Growth Hormone Deficiency1 intervention
Group B: Growth Hormone Deficiency Treatment1 intervention
Trial outcomes
Primary outcomes
1
Quality of Life in Adult Growth Hormone Deficiency Assessment (Qol-AGHDA)
A 25-question, self-administered, condition specific quality of life measure used to determine the extent to which growth hormone deficiency has affected the patient's quality of life. Participants are instructed to answer "yes" or "no" to statements relating to problems with memory and concentration, tiredness, tenseness, social isolation and self-confidence. Higher scores indicate greater symptom burden and lower quality of life.
Time frame
To be completed at baseline and repeated bi-weekly during Genotropin treatment and treatment completion (3 months)2
Glucagon Stimulation Testing
Provocative glucagon stimulation testing completed by endocrinology. Peak growth hormone of less than 3mcg/L indicative of growth hormone deficiency
Time frame
BaselineSecondary outcomes
1
Saint Louis University Mental Status Examination (SLUMS)
Assesses for mild cognitive impairment. Total possible score ranges from 0 to 30, with higher scores indicative of better outcomes.
Time frame
To be assessed at baseline and at completion of treatment (3 months)2
Fatigue and Altered Cognition Scale (FACS)
A 20-item self-reported questionnaire that measures central fatigue and altered cognition, , with 10 items comprising each subscale. Items are rated on an electronic visual analog scale (0-100), with higher scores indicating greater symptom severity.
Time frame
To be repeated bi-weekly during Genotropin treatment and treatment completion (3 months)3
Patient Health Questionnaire - 9 (PHQ-9)
Assesses depressive symptoms. Total possible score ranges from 0-27, with higher scores indicative of worse outcomes.
Time frame
To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)4
Generalized Anxiety Disorder -7 (GAD-7)
Assesses feelings of anxiety. Total possible score ranges from 0-21, with higher scores indicative of worse outcomes.
Time frame
To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov