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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01007071
• Date of registration: 30/10/2009
• Prospective Registration: Yes
• Primary sponsor: Stanford University
• Public title: Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency GHD
• Scientific title: Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults
• Date of first enrolment: November 1, 2009
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01007071
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Laurence Katznelson
• Affiliation: Stanford University

• Name: Era Sidhaye Shah
• Affiliation: Stanford University

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypopituitarism

Intervention(s)

Drug: Placebo

Drug: Human Growth Hormone (1-134)

Primary Outcome(s)

BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI [Time Frame: Baseline and 16 weeks]

Secondary Outcome(s)

Neuropsychological Testing of Executive Function [Time Frame: 16 weeks]

Secondary ID(s)

SU-10022009-4140

IRB eprotocol # 15129

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.

Results

• Results available: Yes
• Date Posted: 17/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01007071