Effects of Short-term Growth Hormone in HIV-infected Patients - Full Text View

Purpose

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.

Condition	Intervention
HIV Lipodystrophy	Drug: Growth hormone Drug: Growth Hormone Releasing Hormone


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Short-term Growth Hormone in HIV-infected Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines HIV/AIDS Hormones

Drug Information available for: Somatropin

Genetic and Rare Diseases Information Center resources: Lipodystrophy Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug [ Time Frame: after 2 weeks treatment ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Insulin Sensitivity [ Time Frame: after two weeks treatment ] [ Designated as safety issue: No ]
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


Enrollment:	25
Study Start Date:	February 2009
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GH 6mcg/kg/d Recombinant human growth hormone 6mcg/kg SC once daily	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 Other Name: rhGH from Teva Pharmaceuticals
Experimental: GH 2mg daily Recombinant human growth hormone 2mg SC once daily	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 Other Name: rhGH from Teva Pharmaceuticals
Experimental: Growth Hormone Releasing Hormone Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks	Drug: Growth Hormone Releasing Hormone Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795210

Locations


United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Principal Investigator:	Steven K Grinspoon, M.D.	Massachusetts General Hospital

More Information

No publications provided


Responsible Party:	Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00795210 History of Changes
Other Study ID Numbers:	DK63639A, R01DK063639
Study First Received:	November 20, 2008
Results First Received:	October 9, 2013
Last Updated:	December 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:


HIV lipodystrophy growth hormone growth hormone releasing hormone

Additional relevant MeSH terms:


Lipodystrophy Lipid Metabolism Disorders Metabolic Diseases Skin Diseases Skin Diseases, Metabolic	Growth Hormone-Releasing Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015