RECRUITING

Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Conditions

Adult Growth Hormone Deficiency Mild Traumatic Brain Injury

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).

Official Title

CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Quick Facts

Study Start:2025-01-13

Study Completion:2028-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04867317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* OEF/OIF/OND Veteran * Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2) * Age 21 - 55 years old * One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey * GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L) and IGF-I lab values have to be less than or equal to +1 SDS at baseline * Score of 11 or more on QoL-AGHDA * 4-week stability on any psychotropic medications * 3-month stability on all other hormone treatments * Able and willing to provide informed consent to participate in this study, and complete study protocol.	* History of moderate or severe TBI * History of neurologic disorder other than TBI with substantial impact on quality of life * History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder * Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months * Contraindication to rhGH therapy * Contraindication to macimorelin use, including QTc interval \>470ms * Acute medical illness, active infection, cancer or decompensated chronic medical illness * Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed. * Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory Malingering (TOMM). * BMI \> 35 or body weight \> 350 lbs * Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass) * Women who are pregnant or of child-bearing potential not on contraception * Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses * Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)

Inclusion Criteria

Exclusion Criteria

* OEF/OIF/OND Veteran
* Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
* Age 21 - 55 years old
* One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey
* GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
* Score of 11 or more on QoL-AGHDA
* 4-week stability on any psychotropic medications
* 3-month stability on all other hormone treatments
* Able and willing to provide informed consent to participate in this study, and complete study protocol.

* History of moderate or severe TBI
* History of neurologic disorder other than TBI with substantial impact on quality of life
* History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
* Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months
* Contraindication to rhGH therapy
* Contraindication to macimorelin use, including QTc interval \>470ms
* Acute medical illness, active infection, cancer or decompensated chronic medical illness
* Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.
* Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory Malingering (TOMM).
* BMI \> 35 or body weight \> 350 lbs
* Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)
* Women who are pregnant or of child-bearing potential not on contraception
* Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
* Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)

Contacts and Locations

Study Contact

Deane V Walker, MHA BS AB

CONTACT

(203) 937-3440

Deane.Walker@va.gov

Michael T Wininger, PhD

CONTACT

(203) 932-5711

michael.wininger@va.gov

Principal Investigator

Jose M. Garcia, MD PhD

STUDY_CHAIR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Locations (Sites)

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125

United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004

United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211

United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Jose M. Garcia, MD PhD, STUDY_CHAIR, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13

Study Completion Date2028-03-01

Study Record Updates

Study Start Date2025-01-13

Study Completion Date2028-03-01

Terms related to this study

Additional Relevant MeSH Terms

Adult Growth Hormone Deficiency
Mild Traumatic Brain Injury