A Phase 2 interventional study of pegvisomant in Diabetes, Metabolic Syndrome and Insulin Resistance, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-24.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 6 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Drug: pegvisomant
Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Also known as: Somavert
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
Time frame: 28 days
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.
Time frame: 28 days
| Milestone | Pegvisomant Arm |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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
| units on a scale | Pegvisomant Arm |
|---|---|
| Baseline HOMA-IR | 3.06 ± 1.46 |
| HOMA-IR after 28 days of treatment | 3.33 ± 2.76 |
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.
| mg/kg/min | Pegvisomant Arm |
|---|---|
| Ra glycerol fasting state baseline | 0.20 ± 0.07 |
| Ra glycerol fasting state after 28 days of peg | 0.21 ± 0.02 |
| Ra glycerol steady state baseline | -0.01 ± 0.2 |
| Ra glycerol steady state treatment 28 days peg | 0.4 ± 0.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegvisomant Arm | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Pegvisomant Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Age, Continuous(years) | Pegvisomant Arm |
|---|---|
| Mean | 56.5 ± 3.6 |
| Sex: Female, Male(Participants) | Pegvisomant Arm |
|---|---|
| Female | 0 |
| Male | 6 |
| Region of Enrollment(participants) | Pegvisomant Arm |
|---|---|
| United States | 6 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco