Current partner codePEPTIDESDE
NCT00795210·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

25

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

DRUG

Growth Hormone Releasing Hormone

Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Timeline

From registration to results.

  1. First posted

    Nov 21, 2008

  2. Study start

    Feb 2009

  3. Primary completion

    Nov 2012

  4. Study completion

    Nov 2012

  5. Results posted

    Jan 8, 2014

  6. Registry updated

    Jan 8, 2014

Outcomes

What the study measures.

Primary outcomes

Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug

Time frame · after 2 weeks treatment

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 outcomes

Insulin Sensitivity

Time frame · after two weeks treatment

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

MGH

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tesamorelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.