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| Name | Class |
|---|---|
| San Francisco General Hospital | OTHER |
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Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegvisomant arm | Experimental | Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegvisomant | Drug | Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR. HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lipolysis | Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethan J Weiss, MD | University of California, San Francisco | Principal Investigator |
| Morris Schambelan, MD | University of California, San Francisco | Principal Investigator |
| Kathleen Mulligan, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegvisomant Arm | Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject. pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegvisomant Arm | pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this 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 | Insulin Sensitivity | Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR. HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 | Patients were compared after treatment to their own baseline | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
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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 | Pegvisomant Arm | pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ethan Weiss | UCSF | 4155140819 | ethan.weiss@ucsf.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C406545 | pegvisomant |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Secondary | Lipolysis | Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant. | Ra glycerol reported | Posted | Mean | Standard Deviation | mg/kg/min | 28 days |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D006946 | Hyperinsulinism |
| Title | Measurements |
|---|---|
|
| Ra glycerol steady state treatment 28 days peg |
|