Healthy Volunteers
Conditions
Keywords
growth hormone releasing hormone
Brief summary
The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.
Detailed description
The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the Tesamorelin and will return for an identical assessment after a 2 week withdrawal period.
Interventions
DRUGGrowth Hormone Releasing Hormone (Tesamorelin)
Tesamorelin 2mg subcutaneous daily x 2 weeks
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Men aged 18-60 years * BMI \> 20kg/m2 and \<35kg/m2
Exclusion criteria
* Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study * Use of GH or growth hormone stimulating peptides within six months of starting the study * Change in lipid lowering or antihypertensive regimen within 3 months of screening * Fasting blood sugar \> 126 mg/dL, SGOT \> 2.5 times ULN, Hgb \< 12.0 g/dL, creatinine \> 1.4 mg/dL * Carpal tunnel syndrome * Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer * For men, history of prostate cancer or evidence of prostate malignancy by PSA \> 5 ng/mL * Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis * Weight \< 110 lbs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Overnight Growth Hormone | at 2 weeks (i.e., after 2 weeks of treatment) | Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Stimulated Glucose Utilization | at 2 weeks (i.e., after 2 weeks of treatment) | Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment. |
Countries
United States
Participant flow
Recruitment details
recruitment from March 2009 through March 2010
Participants by arm
| Arm | Count |
|---|---|
| Growth Hormone Releasing Hormone (Tesamorelin) Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Growth Hormone Releasing Hormone (Tesamorelin) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age Continuous | 44 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
Mean Overnight Growth Hormone
Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.
Time frame: at 2 weeks (i.e., after 2 weeks of treatment)
Population: analysis of 13 participants who completed both baseline and 2 week visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Growth Hormone Releasing Hormone (Tesamorelin) | Mean Overnight Growth Hormone | 1.2 mcg/L | Standard Error 0.3 |
Comparison: Paired t-test comparing baseline and 2 week mean overnight growth hormonep-value: <0.005Paired t-test
Secondary
Insulin Stimulated Glucose Utilization
Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.
Time frame: at 2 weeks (i.e., after 2 weeks of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Growth Hormone Releasing Hormone (Tesamorelin) | Insulin Stimulated Glucose Utilization | 7.5 mg/kg/min | Standard Error 1.2 |
Comparison: Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.p-value: 0.61Paired t-test