Primary outcomeMedian· after 2 weeks treatment
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
| Group | Value (ng/mL) |
|---|---|
| GH 6mcg/kg/d | 0.23 |
| GH 2mg Daily | 0.07 |
| Growth Hormone Releasing Hormone | 1.24 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffects of Short-term Growth Hormone in HIV-infected Patients
This trial does not test a peptide that PepBank tracks.
- Names HGH (somatotropin), does not test it. It appears in the description.
- Names Tesamorelin, does not test it. It appears in the description.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 25 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Feb 2009
- Primary completion
- Nov 2012
- Completion
- Nov 2012
- First posted
- 21 Nov 2008 (estimated)
- Last update posted
- 8 Jan 2014 (estimated)
- Conditions
- HIV Lipodystrophy
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20092010201120122013
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Growth hormoneDrug
- Growth Hormone Releasing HormoneDrug
Arms3
Experimental
GH 6mcg/kg/d
Recombinant human growth hormone 6mcg/kg SC once daily
Experimental
GH 2mg daily
Recombinant human growth hormone 2mg SC once daily
Experimental
Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Primary outcomes1
Outcomes the sponsor listed as primary.
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
Time frame · after 2 weeks treatment
Registry description
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(1)
Insulin Sensitivity
Time frame · after two weeks treatment
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· after two weeks treatment
Insulin Sensitivity
| Group | Value (mg/kg/min) | Spread |
|---|---|---|
| GH 6mcg/kg/d | 9.0 | 2.9 |
| GH 2mg Daily | 7.5 | 3.2 |
| Growth Hormone Releasing Hormone | 9.9 | 1.2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| GH 6mcg/kg/dRecombinant human growth hormone 6mcg/kg SC once daily | – | 0 / 8 | 1 / 8 |
| GH 2mg DailyRecombinant human growth hormone 2mg SC once daily | – | 0 / 11 | 3 / 11 |
| Growth Hormone Releasing HormoneGrowth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks | – | 0 / 3 | 2 / 3 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
PepBank is a research reference. Talk to a doctor before you use any peptide.