Growth Hormone Deficiency
Conditions
Keywords
rhGH, rhIGF-1
Brief summary
The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.
Detailed description
Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that growth hormone (GH) and IGF-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.
Interventions
DRUGRecombinant Human Growth Hormone
300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
Sponsors
Tercica
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass.
Exclusion criteria
* Female gender * current GH use or GH use within three months of the study * diabetes * hypoglycemia * liver or kidney disease * use of drugs that could increase GH secretion (i.e. L-dopa) * alcohol or substance abuse * use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids | 2 months |
| Changes in Endothelial Cell Function | 2 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Subjects Includes all subjects enrolled into the study. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Study Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine
Time frame: 2 months
Population: Levels of cardiovascular serum risk markers were not measured and thus not analyzed due to poor enrollment.
Secondary
Changes in Endothelial Cell Function
Time frame: 2 months
Population: Endothelial cell function was not measured/collected and thus not analyzed due to poor enrollment.
Secondary
Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids
Time frame: 2 months
Population: Visceral adiposity, intrahepatic and intramyocllular lipids were not measured/collected and thus not analyzed due to poor enrollment.