Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effects of Growth Hormone Releasing Hormone in HIV

NCTNCT01263717Other id2007p-000638

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 54 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Dec 2010
Primary completion: Feb 2014
Completion: Feb 2014
First posted: 21 Dec 2010 (estimated)
Last update posted: 30 Oct 2017
Conditions: HIV · HIV Lipodystrophy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012201320142015

N/A
Effects of Growth Hormone Releasing Hormone in HIV
NCT01263717
Dec 2010 to Feb 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

tesamorelinDrug
placeboDrug

Arms2

Experimental
Tesamorelin
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo comparator
Placebo (inactive injection)
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase

Primary outcomes2

Outcomes the sponsor listed as primary.

Liver Fat
Time frame · 6 months
Registry description
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
Registry description
Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.

Secondary outcomes(10)

Intramyocellular Lipid
Time frame · 6 months
Registry description
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
Registry description
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
Registry description
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
Registry description
Hemoglobin A1c.
Insulin Like Growth Factor 1 (IGF-I)
Time frame · 6 months
Registry description
Insulin Like Growth Factor 1 (IGF-I).
Lipid Panel
Time frame · 6 months
Registry description
Fasting lipids. Triglyceride value is given.
Carotid Intimal Medial Thickness (cIMT)
Time frame · 6 months
Registry description
Carotid Intimal Medial Thickness (cIMT).
Glucose Tolerance
Time frame · 6 months
Registry description
Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.
Adiponectin
Time frame · 6 months
Registry description
adiponectin.
Hemostatic Markers
Time frame · 6 months
Registry description
Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 6 months

Liver Fat

Group	Value (Change in hepatic lipid-to-water %)
Tesamorelin	-2.0
Placebo (Inactive Injection)	0.9

Primary outcomeMean· 6 months

Visceral Adipose Tissue

Group	Value (change in cm^2 after 6 months)
Tesamorelin	-34
Placebo (Inactive Injection)	8

Secondary and other outcome results(6)

Secondary outcomeMedian· 6 months

Intramyocellular Lipid

Group	Value (Change in ratio of IMCL/Cr)
Tesamorelin	-1.7
Placebo (Inactive Injection)	-0.2

Secondary outcomeMedian· 6 months

Endogenous Growth Hormone Secretion

Group	Value (Change in ng/mL)
Tesamorelin	0.35
Placebo (Inactive Injection)	-0.01

Secondary outcomeMean· 6 months

Insulin Sensitivity

Group	Value (Change in mg/kg/min)
Tesamorelin	0.4
Placebo (Inactive Injection)	0.7

Secondary outcomeMean· 6 months

HbA1c

Group	Value (Change in %)
Tesamorelin	0.20
Placebo (Inactive Injection)	0.02

Secondary outcomeMean· 6 months

Insulin Like Growth Factor 1 (IGF-I)

Group	Value (Change in ng/mL)	Spread
Tesamorelin	79	92
Placebo (Inactive Injection)	7	62

Secondary outcomeMedian· 6 months

Lipid Panel

Group	Value (Change in triglyceride, mg/dL)
Tesamorelin	-25
Placebo (Inactive Injection)	-10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
TesamorelinTesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose	–	3 / 28	25 / 28
Placebo (Inactive Injection)Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase	–	3 / 22	21 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2017

1 result

Fibroblast growth factor 21 decreases after liver fat reduction via growth hormone augmentation.

Braun et al. 2017Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Societycited by 9

PMID 29031905PMC5705434DOI 10.1016/j.ghir.2017.10.002PUB-29031905

Rights unknown1 result

Source link See results (1)

Indexing hint: Randomized controlled trial · 2014

5 results

Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial.

Stanley et al. 2014JAMAcited by 69

PMID 25038357PMC4363137DOI 10.1001/jama.2014.8334PUB-25038357

Rights unknown5 results

Source link See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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