WithdrawnNot Applicable

Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height

Stopped: Study design no longer relevant and no patients were recruited.

0Started 2009-01

Plain-language summary

The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final height.

Who can participate

Sex

ALL

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: * Patients with SGA treated with growth hormone in one of the following Genotropin studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and after having stopped GH treatment for 5-10 years * Untreated SGA (based on birth weight and/or length below -2 standard deviations \[SDs\] for gestational age) matched to treated SGA by body mass index (+ or = 10%) and gender: * Subjects born SGA with normal final height (within +/- 1.3 SD of their target height); or * Subjects born SGA with short stature (height SDs \> 1.3 below target at final height). Exclusion Criteria: * Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2 * Familial dyslipidemia

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

To demonstrate, that the Insulin Sensitivity Index is not different between GH treated SGA and SGA cohort matched by gender and BMI and not treated with GH that remained short at final height

Timeframe: 90 days

Trial details

NCT IDNCT00396474

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Infant, Small for Gestational Age trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

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