Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK063639 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth Hormone Releasing Hormone | Experimental | Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth Hormone Releasing Hormone (Tesamorelin) | Drug | Tesamorelin 2mg subcutaneous daily x 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 2 weeks (i.e., after 2 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven K Grinspoon, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20943777 | Result | Stanley TL, Chen CY, Branch KL, Makimura H, Grinspoon SK. Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men. J Clin Endocrinol Metab. 2011 Jan;96(1):150-8. doi: 10.1210/jc.2010-1587. Epub 2010 Oct 13. | |
| 21531600 | Derived | Makimura H, Stanley TL, Chen CY, Branch KL, Grinspoon SK. Relationship of adiponectin to endogenous GH pulse secretion parameters in response to stimulation with a growth hormone releasing factor. Growth Horm IGF Res. 2011 Jun;21(3):155-9. doi: 10.1016/j.ghir.2011.03.009. Epub 2011 Apr 30. |
Not provided
Not provided
Not provided
recruitment from March 2009 through March 2010
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Growth Hormone Releasing Hormone (Tesamorelin) | Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Growth Hormone Releasing Hormone (Tesamorelin) | Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | analysis of 13 participants who completed both baseline and 2 week visits | Posted | Mean | Standard Error | mcg/L | at 2 weeks (i.e., after 2 weeks of treatment) |
|
Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug
Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Growth Hormone Releasing Hormone (Tesamorelin) | Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza due to Influenza A virus | Infections and infestations | SNOMED CT | Systematic Assessment | Influenza infection requiring hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pain | Cardiac disorders | SNOMED CT | Systematic Assessment | mild chest pain - EKG, cardiac enzymes, stress test all normal. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Grinspoon, MD | Massachusetts General Hospital | 617-724-9109 | sgrinspoon@partners.org |
Not provided
| ID | Term |
|---|---|
| D013007 | Growth Hormone-Releasing Hormone |
| C479538 | tesamorelin |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| at 2 weeks (i.e., after 2 weeks of treatment) |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Error | mg/kg/min | at 2 weeks (i.e., after 2 weeks of treatment) |
|
|
|
|
| 1 |
| 13 |
| 4 |
| 13 |
|
|
| rash | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | mild rash on dorsum of hands, self-resolved |
|
| Diarrhea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | 2 episodes of watery diarrhea, self-resolved |
|
| Headache | Nervous system disorders | SNOMED CT | Systematic Assessment | 2 mild headaches, self-resolved |
|
| Complaining of itching | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | itching and mild swelling around site of intravenous (IV) catheter, self-resolved |
|
| Dizziness | Nervous system disorders | SNOMED CT | Systematic Assessment | mild dizziness some mornings while on study medication, resolved on discontinuation |
|
| Burn of back | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment |
|
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |