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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK063639 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.
The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 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 treatment and will return for an identical assessment after a 2 week withdrawal period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GH 6mcg/kg/d | Experimental | Recombinant human growth hormone 6mcg/kg SC once daily |
|
| GH 2mg daily | Experimental | Recombinant human growth hormone 2mg SC once daily |
|
| Growth Hormone Releasing Hormone | Experimental | Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth hormone | Drug | Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug | Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling. | after 2 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; "M" value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given | after two weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
Once patients were found to be eligible (after screen visit) and agreed to participate, there were no additional events prior to baseline.
Recruitment occurred between January, 2009 and November, 2012, in the Boston area.
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| ID | Title | Description |
|---|---|---|
| FG000 | GH 6mcg/kg/d | Recombinant human growth hormone 6mcg/kg SC once daily |
| FG001 | GH 2mg Daily | Recombinant human growth hormone 2mg SC once daily |
| FG002 | Growth Hormone Releasing Hormone | Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GH 6mcg/kg/d | Recombinant human growth hormone 6mcg/kg SC once daily |
| BG001 | GH 2mg Daily | Recombinant human growth hormone 2mg SC 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 | Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug | Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling. | Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis. | Posted | Median | Inter-Quartile Range | ng/mL | after 2 weeks treatment |
|
AE data were actively collected during the 4 weeks of the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GH 6mcg/kg/d | Recombinant human growth hormone 6mcg/kg SC once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders |
The study was completed early due to the lack of availability of study drug for one of the arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Grinspoon, MD | Massachusetts General Hospital | 617-724-9109 | sgrinspoon@partners.org |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D013007 | Growth Hormone-Releasing Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Growth Hormone Releasing Hormone | Drug | Tesamorelin (GHRH) 2mg SC QD x 2 weeks |
|
| BG002 | Growth Hormone Releasing Hormone | Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Recombinant human growth hormone 2mg SC once daily |
| OG002 | Growth Hormone Releasing Hormone | Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks |
|
|
|
| Secondary | Insulin Sensitivity | insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; "M" value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given | Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used. | Posted | Mean | Standard Deviation | mg/kg/min | after two weeks treatment |
|
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | GH 2mg Daily | Recombinant human growth hormone 2mg SC once daily | 0 | 11 | 3 | 11 |
| EG002 | Growth Hormone Releasing Hormone | Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks | 0 | 3 | 2 | 3 |
| Sinus Infection | Respiratory, thoracic and mediastinal disorders |
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| Edema/Extremity Swelling | Blood and lymphatic system disorders |
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| hyperglycemia | Endocrine disorders | elevated fasting blood sugar |
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| injection site bruising | Skin and subcutaneous tissue disorders |
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| headache | Nervous system disorders |
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| dizziness | Nervous system disorders |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |