CompletedNCT02988687Updated Mar 6, 2023

Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD

An observational study in Adult-Onset Growth Hormone Deficiency, sponsored by Garcia, Jose M., MD, PhD. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by Garcia, Jose M., MD, PhD · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 7
Ages: 18 Years to 65 Years
Sex: All

Study summary

This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period of six months and collect valuable pilot data to evaluate feasibility of a larger study and treatment tolerability and compliance. The effect of rhGH on cognitive function, depression, fatigue, sleep quality, and QOL will also be collected. This exploratory study will also provide important information about recruitment and AGHD screening procedures in military settings.

Read the detailed description

Growth hormone replacement has consistently shown improvements in body composition, exercise capacity, endothelial function, inflammatory biomarkers, bone mineral density, lipoprotein metabolism, and self-reported quality of Life (QOL) in patients suffering from adult growth hormone deficiency (AGHD). One of the causes for AGHD is traumatic brain injury (TBI), a condition that affects approximately 20% of Veterans from Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND). Because OIF/OEF/OND Veterans are a new population, there is a paucity of data regarding the effects of rhGH in these patients. The investigators propose to perform a pilot observational study of Veterans with confirmed adult growth hormone deficiency (AGHD) due to TBI who have been prescribed recombinant human growth hormone (rhGH) replacement in order to determine changes in metabolic parameters and QOL induced by rhGH.

Our hypothesis is that GH replacement will improve QOL and metabolic parameters (glucose, insulin resistance, lipids, inflammatory markers, and body composition) in patients with confirmed AGHD due to TBI.The primary aim for this proposal is to determine the effects of rhGH treatment given daily for 6 months to Veterans with TBI and AGHD on QoL measured by the Quality of Life Assessment for GHD in Adults questionnaire (QoL-AGHDA, primary outcome). Secondary specific aims for this proposal are to gather high quality pilot data of the effects of 6 months of rhGH replacement in Veterans with TBI and AGHD.

Conditions studied

Adult-Onset Growth Hormone Deficiency

Browse trials for

Keywords

fatigue
quality of life
depression
cognitive function
growth hormone
traumatic brain injury

In context

Fatigue

1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 375 observational studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Garcia, Jose M., MD, PhD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Veterans being prescribed rhGH replacement for Adult Onset Growth Hormone Deficiency due to Traumatic Brain Injury

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

OEF/OIF/OND deployment confirmed by available records
history of combat exposure during deployment as determined by a score greater than 1 on the Combat Experiences sub-scale of the Deployment Risk and Resilience Inventory-2 (DRRI-2)
age >18 years
a history of TBI defined according to the DoD/VA guidelines and characterized by the Ohio State TBI Inventory
history of AGH deficiency diagnosed by: a) a GH stimulatory test; or b) low plasma IGF-1 level and 3 pituitary hormone deficiencies
have been prescribed rhGH replacement by a clinical provider
If the Veteran is receiving psychotropic medications he should be on stable doses for at least 4 weeks before their enrollment in the study.

Exclusion criteria

Exclusion Criteria:

Other untreated pituitary deficiencies [patients with other hormone deficiencies will have to be on stable replacement for at least three months before including them on the study; two months of stable replacement is required for hydrocortisone therapy for adrenal insufficiency]
tumors, or other causes of AGHD (e.g. childhood onset GHD, pituitary surgery, tumors, radiation)
history of neurologic or psychiatric disorder such as stroke, spinal cord injury, bipolar disorder, or schizophrenia that has a significant impact in the Veteran's functional status and QoL
contraindication to rhGH therapy (e.g. hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol)
acute medical illness, active infection, neoplastic disease or decompensated chronic medical illness such as diabetes mellitus (A1c >9%), congestive heart failure or chronic obstructive pulmonary disease
evidence of alcohol dependence, alcohol abuse or drug use disorder during the three months previous to enrollment in the study
evidence of inadequate levels of effort in performing neuropsychological tests as suggested by scoring less than 41 on Trial I of the Test of Memory and Malingering (TOMM)
due to the decreased specificity of the AGHD diagnostic tests in this setting and weight/size limitations of the DEXA scanner, we will exclude morbid obese subjects defined as having a BMI greater than 35 or body weight > 350 lbs
use of rhGH in the previous 6 months
active or recent (6 months) history of coronary artery or cerebrovascular disease

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 7 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

AGHDA change
Quality of Life Assessment for GHD in Adults questionnaire
Time frame: baseline to 3 months
AGHDA change
Quality of Life Assessment for GHD in Adults questionnaire
Time frame: baseline to 6 months

Secondary outcomes

Body composition change
Lean body mass and fat mass by dual energy x-ray absorptiometry
Time frame: baseline to 6 months
CVLT change
Memory performance measured by the California Verbal Learning
Time frame: baseline to 6 months
DASS-21 change
Depressive and anxiety symptoms measured by the Depression Anxiety and Stress Scale
Time frame: baseline to 6 months

Other outcomes

muscle strength change
1-RM and hand grip strength (both in kg)
Time frame: baseline to 6 months
Aerobic capacity change
VO2 max
Time frame: baseline to 6 months
Muscle function change
chair stand test
Time frame: baseline to 6 months
Muscle function change
stair climb power
Time frame: baseline to 6 months
Fatigue change
QOL AGHD subsection
Time frame: baseline to 6 months
Sleep quality change
Pittsburgh Sleep Quality Index
Time frame: baseline to 6 months
Inflammatory marker changes
systemic cytokine levels
Time frame: baseline to 6 months
Anabolic marker changes
systemic IGF-1 and IGFBP3 levels (both ng/mL)
Time frame: baseline to 6 months
Chronic pain change
Brief Pain Inventory
Time frame: baseline to 6 months

Study locations

1 site

VA Puget Sound Health Care System
Seattle, Washington 98108, United States

References and documents

Publications

Herodes M, Le N, Anderson LJ, Migula D, Miranda G, Paulsen L, Garcia JM. Metabolic and quality of life effects of growth hormone replacement in patients with TBI and AGHD: A pilot study. Growth Horm IGF Res. 2023 Aug;71:101544. doi: 10.1016/j.ghir.2023.101544. Epub 2023 Jun 1. PubMed 37295336 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2016, a primary completion of Oct 2022 and a completion of Oct 2022. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 17, 2016
First posted: Dec 9, 2016
Start: Nov 2016
Primary completionActual: Oct 2022
CompletionActual: Oct 2022
Last update: Mar 6, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02988687
Lead sponsor: Garcia, Jose M., MD, PhD
Responsible party: Sponsor
First posted: Dec 9, 2016
Start date: Nov 2016
Primary completion: Oct 2022
Completion: Oct 2022
Last update: Mar 6, 2023

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fatigue →

Other studies from this sponsor

Garcia, Jose M., MD, PhD

Start the discussion