Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

NCTNCT00850564Other idDK63639BOther idR01DK063639

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 15 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Feb 2009
Primary completion: Apr 2010
Completion: Apr 2010
First posted: 25 Feb 2009 (estimated)
Last update posted: 19 Apr 2011 (estimated)
Conditions: Healthy Volunteers

Timeline

1 trial · 1 completed · 1 with posted results

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

200920102011

N/A
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
NCT00850564
Feb 2009 to Apr 2010

Registry summary

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

The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.

Interventions

Growth Hormone Releasing Hormone (Tesamorelin)Drug

Arms1

Experimental
Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Overnight Growth Hormone
Time frame · at 2 weeks (i.e., after 2 weeks of treatment)
Registry description
Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.

Secondary outcomes(1)

Insulin Stimulated Glucose Utilization
Time frame · at 2 weeks (i.e., after 2 weeks of treatment)
Registry description
Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.

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 outcomeMean· at 2 weeks (i.e., after 2 weeks of treatment)

Mean Overnight Growth Hormone

Group	Value (mcg/L)	Spread
Growth Hormone Releasing Hormone (Tesamorelin)	1.2	0.3

Secondary and other outcome results(1)

Secondary outcomeMean· at 2 weeks (i.e., after 2 weeks of treatment)

Insulin Stimulated Glucose Utilization

Group	Value (mg/kg/min)	Spread
Growth Hormone Releasing Hormone (Tesamorelin)	7.5	1.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Growth Hormone Releasing Hormone (Tesamorelin)Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily	–	1 / 13	4 / 13

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

PubMed tag: none · 2011

6 results

Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men.

Stanley et al. 2011The Journal of clinical endocrinology and metabolismcited by 42

PMID 20943777PMC3038486DOI 10.1210/jc.2010-1587PUB-20943777

Rights unknown6 results

Source link See results (6)

Indexing hint: Clinical trial · 2011

4 results

Relationship of adiponectin to endogenous GH pulse secretion parameters in response to stimulation with a growth hormone releasing factor.

Makimura et al. 2011Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Societycited by 5

PMID 21531600PMC3112279DOI 10.1016/j.ghir.2011.03.009PUB-21531600

Rights unknown4 results

Source link See results (4)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Men aged 18-60 years * BMI \> 20kg/m2 and \<35kg/m2 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 stimulating peptides within six months of starting the study * Change in lipid lowering or antihypertensive regimen within 3 months of screening * Fasting blood sugar \> 126 mg/dL, SGOT \> 2.5 times ULN, Hgb \< 12.0 g/dL, creatinine \> 1.4 mg/dL * 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 \> 5 ng/mL * Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis * Weight \< 110 lbs.

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