Adult-Onset Growth Hormone DeficiencyNCT02988687
Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD
An observational study of Adult-Onset Growth Hormone Deficiency, run by Garcia, Jose M., MD, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult-Onset Growth Hormone Deficiency
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans being prescribed rhGH replacement for Adult Onset Growth Hormone Deficiency due to Traumatic Brain Injury
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Metabolic and Quality of Life Effects of Growth Hormone Treatment in Patients With Traumatic Brain Injury and AGHD
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
- Adult-Onset Growth Hormone Deficiency
- Keywords
- fatigue, quality of life, depression, cognitive function, growth hormone, traumatic brain injury
- Medical subject headings
- Fatigue, Depression, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
AGHDA change
Quality of Life Assessment for GHD in Adults questionnaire
Measured: baseline to 3 months
AGHDA change
Quality of Life Assessment for GHD in Adults questionnaire
Measured: baseline to 6 months
Secondary outcomes (3)
Body composition change
Lean body mass and fat mass by dual energy x-ray absorptiometry
Measured: baseline to 6 months
CVLT change
Memory performance measured by the California Verbal Learning
Measured: baseline to 6 months
DASS-21 change
Depressive and anxiety symptoms measured by the Depression Anxiety and Stress Scale
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult-Onset Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garcia, Jose M., MD, PhD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988687
- Sponsor's protocol ID
- 00930
- Status last verified
- Aug 2022
- First submitted
- 17 Nov 2016
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Quality of Life Effects of Growth Hormone Treatment in Patients With Traumatic Brain Injury and AGHD
- ClinicalTrials.gov ID
- NCT02988687
- Acronym / sponsor ID
- 00930
- Conditions
- Adult-Onset Growth Hormone Deficiency
- Keywords
- fatigue, quality of life, depression, cognitive function, growth hormone, traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Garcia, Jose M., MD, PhD
- Study start
- Nov 2016
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans being prescribed rhGH replacement for Adult Onset Growth Hormone Deficiency due to Traumatic Brain Injury
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AGHDA change
Time frame: baseline to 3 months
Quality of Life Assessment for GHD in Adults questionnaire
AGHDA change
Time frame: baseline to 6 months
Quality of Life Assessment for GHD in Adults questionnaire
3 secondary outcomes
Body composition change
Time frame: baseline to 6 months
CVLT change
Time frame: baseline to 6 months
DASS-21 change
Time frame: baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 37295336Herodes 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult-Onset Growth Hormone Deficiency, run by Garcia, Jose M., MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AGHDA change (time frame: baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.