Andrew R. Hoffman
Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Human Growth hormone - nutropin
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 65 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
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)
Additional Study Details
Official Title:
Effects of Growth Hormone on Cognition and Cerebral Metabolism in AdultsAnticipated start date:
11/15/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- Genentech
Investigator(s):
- Laurence Katznelson
- Era Sidhaye Shah
- Andrew R Hoffman
- Michael D Greicius
- Jennifer Keller
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
Assignment:
ParallelEndpoints:
N/APrimary Outcomes:
- cogniitive function
- functonal neuroimaging
Total Number to be Enrolled:
22Total Number to be Enrolled at Stanford:
22More Information
Secondary ID(s):
- IRB eprotocol # 15129
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
10/27/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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