NCT00850564

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 30, 2011

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

1.2 years

First QC Date

February 23, 2009

Results QC Date

March 3, 2011

Last Update Submit

April 15, 2011

Conditions

Healthy Volunteers

Keywords

growth hormone releasing hormone

Outcome Measures

Primary Outcomes (1)

  • Mean Overnight Growth Hormone

    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.

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

Secondary Outcomes (1)

  • Insulin Stimulated Glucose Utilization

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

Study Arms (1)

Growth Hormone Releasing Hormone

EXPERIMENTAL

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

Drug: Growth Hormone Releasing Hormone (Tesamorelin)

Interventions

Growth Hormone Releasing Hormone (Tesamorelin)DRUG

Tesamorelin 2mg subcutaneous daily x 2 weeks

Also known as: Tesamorelin
Growth Hormone Releasing Hormone

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 18-60 years
  • BMI \> 20kg/m2 and \<35kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Stanley TL, Chen CY, Branch KL, Makimura H, Grinspoon SK. Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men. J Clin Endocrinol Metab. 2011 Jan;96(1):150-8. doi: 10.1210/jc.2010-1587. Epub 2010 Oct 13.

    PMID: 20943777RESULT

  • Makimura H, Stanley TL, Chen CY, Branch KL, Grinspoon SK. Relationship of adiponectin to endogenous GH pulse secretion parameters in response to stimulation with a growth hormone releasing factor. Growth Horm IGF Res. 2011 Jun;21(3):155-9. doi: 10.1016/j.ghir.2011.03.009. Epub 2011 Apr 30.

    PMID: 21531600DERIVED

MeSH Terms

Interventions

Growth Hormone-Releasing Hormonetesamorelin

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Steven Grinspoon, MD
Organization
Massachusetts General Hospital
sgrinspoon@partners.org
617-724-9109

Study Officials

  • Steven K Grinspoon, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 19, 2011

Results First Posted

March 30, 2011

Record last verified: 2011-04

Locations

US(1)