TerminatedPhase 1/2

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

Stopped: Poor enrollment

United States5 participantsStarted 2008-01

Plain-language summary

The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.

Who can participate

Age range

25 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass. Exclusion Criteria: * Female gender * current GH use or GH use within three months of the study * diabetes * hypoglycemia * liver or kidney disease * use of drugs that could increase GH secretion (i.e. L-dopa) * alcohol or substance abuse * use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine

Timeframe: 2 months

Trial details

NCT IDNCT00684957

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2016-08-04

View on ClinicalTrials.gov More Growth Hormone Deficiency trials