Effects of Short-term Growth Hormone in HIV-infected Patients
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Endocrine |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/11/2012 |
| Start Date: | February 2009 |
| End Date: | October 2012 |
| Contact: | Takara L Stanley, MD |
| Email: | tstanley@parnters.org |
| Phone: | 617-726-5312 |
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.
Inclusion Criteria:
- previously diagnosed HIV infection
- Stable antiretroviral regimen for at least 12 weeks prior to enrollment
- Waist circumference >/= 95cm and waist-to-hip ratio >/= 0.94 for males or waist
circumference >/=94cm and WHR >/= 0.88 for females, occurring in the context of
treatment for HIV disease
- Subjective evidence of at least one of the following changes, occurring during the
treatment of HIV disease: increased abdominal girth, relative loss of fat in the
extremities, or relative loss of fat in the face
Exclusion Criteria:
- Use of anti-diabetic agents, Megace, testosterone, or any steroid use within 6 months
of the study
- Use of GH or Growth hormone releasing factor within six months of starting the study
- Change in lipid lowering or antihypertensive regimen within 3 months of screening
- Fasting blood sugar >126mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine >
1.4 mg/dL, FSH > 20 IU/L in women, or CD4 count < 200
- Carpal tunnel syndrome
- Severe chronic illness or active malignancy or history of pituitary malignancy or
history of colon cancer
- For men, history of prostate cancer or evidence of prostate malignancy by PSA >
5ng/mL
- Prior history of hypopituitarism, head irradiation, or any other condition known to
affect the GH axis
- positive beta-HCG (women only)
- Oral contraceptives, depo provera, or combined progesterone-estrogen injections,
transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months
of the study
- weight < 110 pounds
We found this trial at
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