Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency

Short name GHD

NCTNCT01007071Other idSU-10022009-4140Other idIRB eprotocol # 15129

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 11 participants (actual)
Sponsor: Stanford University · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 1 Nov 2009
Primary completion: 12 Dec 2012
Completion: 12 Dec 2012
First posted: 3 Nov 2009 (estimated)
Last update posted: 17 Nov 2017
Conditions: Hypopituitarism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 3
GHD
NCT01007071
1 Nov 2009 to 12 Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Patients with Growth hormone (GH) deficiency often report impaired quality of life and difficulty with mental functioning. It has been suggested that GH replacement in such patients leads to improvement in cognitive function. The aim of this study is to elucidate the effects of GH replacement in patients with GH deficiency on cognitive function using structural and functional neuroimaging and cognitive testing.

Interventions

Human Growth Hormone (1-134)Drug
PlaceboDrug

Arms2

Experimental
Growth hormone
Subjects randomized to growth hormone (1-134) for 16 weeks. In this arm, growth hormone is dosed sc on a daily basis and increased over first 6 weeks (Men: start at 0.2 mg sc/d, increase to 0.6 mg sc/d after 4 weeks. Women, postmenopausal: start at 0.3 mg sc/d, increase to 0.9 mg sc/d after 4 weeks. Dose adjustments based on serum insulin-like growth factor-1 (IGF-1) levels at 6 and 12 weeks, with final IGF-1 measurement for efficacy performed at 16 weeks, with goal in range of -0.5 standard deviation (SD) to +2SD. An elevated serum IGF-1 value will result in a 20% dose reduction in GH in an active and random placebo patient. Similarly, a low serum IGF-1 will result in a 20% dose increase in an active and random placebo subject.
Placebo comparator
Placebo
Subjects randomized to placebo for 16 weeks. As noted above, placebo subjects will be initiated on a daily subcutaneous injection, with dose changes based on changes in active drug subjects.

Primary outcomes1

Outcomes the sponsor listed as primary.

BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI
Time frame · Baseline and 16 weeks
Registry description
Functional MRI scans were to be performed at baseline and at 16 weeks. Changes in functional connectivity before and after 16 weeks of treatment were analyzed. The analysis involved approximately 40,000 paired sample t-tests. The dependent variable here for each subject is the correlation between the BOLD timeseries in the seed region (posterior cingulate cortex) and the BOLD timeseries in a given, standard space, brain voxel. This paired-sample t-test is run, separately, for every voxel in the brain. The pre-specified Outcome Measure intended to report the number of voxels that showed significant changes with active treatment. A preliminary analysis was conducted using a paired-sample t-test at each of the 40,000+ voxels, however, none of the voxels reached the level of significance. Since no significant voxels were detected, subsequent planned analyses were not performed, and summary level data cannot be reported for this Outcome Measure.

Secondary outcomes(1)

Neuropsychological Testing of Executive Function
Time frame · 16 weeks
Registry description
Executive function was assessed in part B of the 2-part Trail Making Test. In Part A, 25 circles are distributed over a sheet of paper, numbered 1 - 25, and the patient draws lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient is instructed to connect the circles as quickly as possible. The amount of time the patient takes to connect the circles is recorded as their score. If patients make an error, they are corrected then continue from the last correct circle. The number of seconds for completion of part B is reported, therefore higher scores reveal greater impairment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Baseline and 16 weeks

BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI

Group	Value
Growth Hormone	not posted
Placebo	not posted

Secondary and other outcome results(1)

Secondary outcomeMean· 16 weeks

Neuropsychological Testing of Executive Function

Group	Value (seconds)	Spread
Growth Hormone	69.4	4.5
Placebo	77.6	25.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Human Growth Hormone (1-134)This arm received study drug for 16 weeks. There were no serious adverse events.	0 / 6	0 / 6	0 / 6
PlaceboThis arm received placebo for 16 weeks. There were no serious adverse evens in this group.	0 / 5	0 / 5	1 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age 18-65 years old * Both men and women * Naive to GH replacement therapy * Diagnosis of Growth Hormone deficiency, adult onset * Good general health * Normal thyroid, adrenal or gonadal function, or stable thyroid, glucocorticoid (at replacement doses) and gonadal replacement therapy for at least 3 months prior to study initiation. If subjects are receiving transdermal testosterone, attainment of mid-normal serum values will be considered adequate. If subjects are on intramuscular testosterone, attainment of mid-normal serum testosterone at mid-injection cycle will be considered adequate Exclusion Criteria: * Pregnancy (positive pregnancy test) prior to enrollment in the study * Any other condition that the investigator believes would pose a significant hazard to the subject if Growth Hormone therapy was initiated * Idiopathic Growth Hormone Deficiency * DSM IV diagnosis of Major Depressive Disorder with or without psychotic features, Bipolar II Disorder with or without psychotic features in a major depressive episode * Current use of psychotropic medications * History of moderate to severe brain injury * Clinically significant cardiovascular disease * Anemia with hct\<30 * Renal insufficiency with creatinine \>2.0 * Recent history of excessive alcohol use * Participation in another simultaneous medical investigation or trial * Active neoplasm * Prader Willi Syndrome * History of brain radiation * Chemotherapy, past or present use * History of head or eye injury involving persistent metal fragments, and implanted electrical device (such as a heart pacemaker)

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