Effects of Short-term Growth Hormone in HIV-infected Patients

HIV Lipodystrophy Clinical Trial

Official title:

Effects of Short-term Growth Hormone in HIV-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795210
• Other study ID #: DK63639A
• Secondary ID: R01DK063639
• Status: Completed
• Phase: N/A
• First received: November 20, 2008
• Last updated: December 6, 2013
• Start date: February 2009
• Est. completion date: November 2012

Study information

• Verified date: October 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Lipodystrophy
• Lipodystrophy

Intervention

Drug:
• Growth hormone
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
• Growth Hormone Releasing Hormone
Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	after 2 weeks treatment	No
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	after two weeks treatment	No