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| ID | Type | Description | Link |
|---|---|---|---|
| Tercica-001 | Other Identifier | Tercica |
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Poor enrollment
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| Name | Class |
|---|---|
| Tercica | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Growth Hormone first | Active Comparator | Subjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks. |
|
| Recombinant Human IGF-1 | Active Comparator | Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Growth Hormone | Drug | 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids | 2 months | |
| Changes in Endothelial Cell Function | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela U. Freda, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University, College of Physicians and Surgeons | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1 | Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels) |
| FG001 | Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone | Subjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Subjects | Includes all subjects enrolled into the study. |
| 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 | Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine | Levels of cardiovascular serum risk markers were not measured and thus not analyzed due to poor enrollment. | Posted | 2 months |
|
|
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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 | Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1 | Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Freda, MD | Columbia University | 212-305-3725 | puf1@columbia.edu |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Recombinant Human IGF-1 | Drug | 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels) |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Secondary | Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids | Visceral adiposity, intrahepatic and intramyocllular lipids were not measured/collected and thus not analyzed due to poor enrollment. | Posted | 2 months |
|
|
| Secondary | Changes in Endothelial Cell Function | Endothelial cell function was not measured/collected and thus not analyzed due to poor enrollment. | Posted | 2 months |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone | Subjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels) | 0 | 3 | 0 | 3 | 0 | 3 |
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| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |