NCT07795736

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jun 2024Nov 2028

Study Start

First participant enrolled

June 1, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

August 31, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

Growth Hormone DeficiencyTraumatic Brain Injury

Keywords

ConcussionPersistent post-concussion symptomsTraumatic brain injuryGrowth hormone deficiencyHypopituitarismQuality of LifeGrowth hormone replacement therapyPost-traumatic hypopituitarism

Outcome Measures

Primary Outcomes (2)

  • 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.

    To be completed at baseline and repeated bi-weekly during Genotropin treatment and treatment completion (3 months)

  • Glucagon Stimulation Testing

    Provocative glucagon stimulation testing completed by endocrinology. Peak growth hormone of less than 3mcg/L indicative of growth hormone deficiency

    Baseline

Secondary Outcomes (16)

  • Saint Louis University Mental Status Examination (SLUMS)

    To be assessed at baseline and at completion of treatment (3 months)

  • Fatigue and Altered Cognition Scale (FACS)

    To be repeated bi-weekly during Genotropin treatment and treatment completion (3 months)

  • Patient Health Questionnaire - 9 (PHQ-9)

    To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)

  • Generalized Anxiety Disorder -7 (GAD-7)

    To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)

  • Rivermead Post-Concussion Symptom Questionnaire (RPQ)

    To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)

  • +11 more secondary outcomes

Study Arms (2)

Suspected Growth Hormone Deficiency

Participants attending the Calgary Brain Injury Program or Chronic Pain Centre with persistent post-concussion symptoms for over 1 year suspected of having GHD. Participants will be asked to complete the QoL-AGHDA and additional post-concussion symptom questionnaires and referred to endocrinology for provocative testing (glucagon stimulation testing)

Other: Not applicable (observational study)

Growth Hormone Deficiency Treatment

Participants with GHD (peak GH of \< 5 mcg/L following glucagon stimulation test (GST) will be provided with growth hormone replacement (Genotropin, starting dose 0.2 ug/L and 0.3ug/L for women taking exogenous oral estrogen, Pfizer) for 3 months. Participants will repeat the QoL-AGHDA and exploratory outcome questionnaires bi-weekly throughout treatment (3-months).

Other: Not applicable (observational study)

Interventions

Not applicable (observational study)OTHER

Not applicable (observational study)

Growth Hormone Deficiency TreatmentSuspected Growth Hormone Deficiency

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have sustained a traumatic brain injury and have persisting symptoms lasting beyond 1 year post-injury.

You may qualify if:

  • In terms of concomitant therapies and medication, all prescription and non-prescription medications (e.g., over-the-counter drugs and herbal supplements) and therapies will be recorded by participants during baseline assessments. Participants with GHD on treatment will be asked to disclose any changes in medications/and or therapies at each bi-weekly follow up questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foothills Medical Center, Main Floor Special Services

Calgary, Alberta, T2N2T9, Canada

NOT YET RECRUITING

University of Calgary

Calgary, Alberta, T3G 5N2, Canada

RECRUITING

MeSH Terms

Conditions

Dwarfism, PituitaryBrain Injuries, TraumaticBrain ConcussionHypopituitarism

Interventions

Observation

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrinePituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Chantel T Debert, MD MSc FRCPC CSCN

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantel T Debert, MD MSc FRCPC CSCN

CONTACT

(403) 944-4500cdebert@ucalgary.ca

Christina Campbell, MSc

CONTACT

403-944-8649christina.campbel1@ucalgary.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

June 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

August 31, 2026

Record last verified: 2026-07

Locations

CA(2)