Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01007071
First received: October 30, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Hypopituitarism
Drug: Human Growth hormone - nutropin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • cognitive function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • functional neuroimaging [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Eligibility screening: Diagnosis of GHD will be based on standard testing, including a blunted GH response to stimulation with glucagon provocation, defined as GH <3 microgram/l. Subjects with adult-onset GH deficiency will be included if they are age 18-65 years old, naive to GH replacement therapy, in good general health, and on stable thyroid, glucocorticoid (at replacement doses) and gonadal replacement therapy for at least 6 weeks prior to study initiation. Patients with history a Major Depression will be excluded.

Baseline: Qualifying subjects will be admitted to the CTRU for the following: Weight, body mass index, waist/hip ratio, menstrual cycle history on female subjects and vital signs. Initial clinical laboratory assessments will include IGF-1, a complete blood count, liver function tests, free T4, and a serum pregnancy test for women. Subjects will undergo 3 hours of neuropsychological testing when attention, working memory, executive function and verbal memory will be assessed with the Wechsler Adult Intelligence Scale III and Wechsler Memory Scale (WMS III). Quality of life and mood will be quantified through the Quality of Life Scale, Hamilton Rating Scale for Depression and the Quality of Life Assessment of Growth Hormone Deficiency in Adults (Qol AGHDA). After a lunch break, the patients will undergo a 1 hour MRI scan. Resting images will be obtained, and thereafter simple letters, words or pictures will be projected to subjects while in the scanner. The subjects will be asked simple questions relating to these stimuli.

Randomization and treatment: Following completion of the baseline measurements, study participants will be randomized in a double blind fashion to receive either active treatment with GH or placebo for a period of 16 weeks. GH dosages will be increased incrementally over the first 6 weeks. At 16 weeks, all subjects randomized to placebo will be switched to GH in an open label fashion with dose schedules based on the above titration. Subjects initially randomized to GH will continue to receive GH with their endocrinologist without further follow up for the study.

For efficacy measures, neuropsychological testing and fMRI will be performed at baseline and at 16 weeks, and, for subjects initially randomized to placebo, repeat studies will be performed at 32 weeks.

Safety monitoring will include assessment of changes in thyroid and adrenal status, as well as changes in liver function.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007071

Contacts
Contact: Laurence Katznelson, MD (650) 721-1020 lkatznelson@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Laurence Katznelson, MD    650-721-1020    lkatznelson@stanford.edu   
Contact: Era S Shah, MD    (650) 721-1020    erashah@stanford.edu   
Principal Investigator: Laurence Katznelson         
Sub-Investigator: Era Sidhaye Shah         
Sub-Investigator: Andrew R Hoffman         
Sub-Investigator: Michael D Greicius         
Sub-Investigator: Jennifer Keller         
Sponsors and Collaborators
Stanford University
Genentech
Investigators
Sub-Investigator: Era Sidhaye Shah Stanford University
Principal Investigator: Laurence Katznelson Stanford University
  More Information

No publications provided

Responsible Party: Laurence Katznelson, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01007071     History of Changes
Other Study ID Numbers: SU-10022009-4140, IRB eprotocol # 15129
Study First Received: October 30, 2009
Last Updated: November 2, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014