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NCT01263717·Not applicable·INTERVENTIONAL

Effects of Growth Hormone Releasing Hormone in HIV

TesamorelinOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

54

Locations

1

Results

Posted

Publications

2

Study summary

What the protocol is testing.

HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness \[cIMT\]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism.

Interventions

Treatment arms and agents.

DRUG

tesamorelin

Tesamorelin (growth hormone releasing hormone) 2mg daily given by subcutaneous injection x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose

DRUG

placebo

Placebo 2mg daily given by subcutaneous injection for the first 6 months of the study, followed by an open-label phase of 6 months of tesamorelin (growth hormone releasing hormone) treatment, 2mg daily given by subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Dec 21, 2010

  2. Study start

    Dec 2010

  3. Primary completion

    Feb 2014

  4. Study completion

    Feb 2014

  5. Results posted

    Oct 13, 2014

  6. Registry updated

    Oct 30, 2017

Outcomes

What the study measures.

Primary outcomes

Liver Fat

Time frame · 6 months

Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).

Visceral Adipose Tissue

Time frame · 6 months

Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.

Secondary outcomes

Intramyocellular Lipid

Time frame · 6 months

Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.

Endogenous Growth Hormone Secretion

Time frame · 6 months

Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.

Insulin Sensitivity

Time frame · 6 months

In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.

HbA1c

Time frame · 6 months

Hemoglobin A1c.

Insulin Like Growth Factor 1 (IGF-I)

Time frame · 6 months

Insulin Like Growth Factor 1 (IGF-I).

Lipid Panel

Time frame · 6 months

Fasting lipids. Triglyceride value is given.

Carotid Intimal Medial Thickness (cIMT)

Time frame · 6 months

Carotid Intimal Medial Thickness (cIMT).

Glucose Tolerance

Time frame · 6 months

Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.

Adiponectin

Time frame · 6 months

adiponectin.

Hemostatic Markers

Time frame · 6 months

Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.

Eligibility

Who can take part.

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

Inclusion Criteria: 1. Men and women age 18-65 2. Previously diagnosed HIV infection 3. Stable antiviral regimen for at least 12 weeks prior to enrollment 4. WC\>95 cm and WHR\>0.94 for male, WC\>94 cm and WHR\>0.88 for female occurring in the context of treatment for HIV disease 5. Subjective evidence of at least one of the following recent 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 6. For female subjects 40yo or older, negative mammogram within one year of baseline Exclusion Criteria: 1. Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study. Stable use of testosterone (\> 6 mos) at dose equivalent to 200 mg IM q 2 weeks or \< 10g/day to skin will be permitted. 2. Use of GH or GHRH within the past 6 months 3. Change in lipid lowering or antihypertensive regimen within 3 months of screening 4. Fasting blood sugar \> 126 mg/dL, SGOT \> 2.5 times ULN, HgB \< 12.0 g/dL, creatinine \> 1.4 mg/dL, CD4 count \< 200 5. Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer 6. For men, history of prostate cancer or evidence of prostate malignancy by PSA \> 5 ng/mL 7. Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis 8. For women, positive urine hCG 9. Oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study. 10. Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip.

Study locations

1 registered sites.

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

Massachusetts General Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

PMID 25038357 ↗Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):380-9. doi: 10.1001/jama.2014.8334.PMID 29031905 ↗Braun LR, Feldpausch MN, Czerwonka N, Torriani M, Grinspoon SK, Stanley TL. Fibroblast growth factor 21 decreases after liver fat reduction via growth hormone augmentation. Growth Horm IGF Res. 2017 Dec;37:1-6. doi: 10.1016/j.ghir.2017.10.002. Epub 2017 Oct 7.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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