Phase 4 Completed N=9 Treatment

Growth Hormone and Endothelial Function in Children

Growth Hormone Deficiency · Panhypopituitarism · Short Stature

Source: ClinicalTrials.gov NCT00373386 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcomePrimary: Reactive Hyperemic Response After 3 Months of Growth Hormone — 21.077 ml/dl min — p=0.644

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

Objective: This study is designed to determine whether growth hormone treatment in children 8 to 18 years of age alters function of the lining of the arteries. This may play a role in increasing or decreasing the risk of heart disease. Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be studied before and 3 months after starting growth hormone. Subjects can be on other hormonal replacements but no other medications. Each study will be done in the fasting state. The blood vessel function will be determined by measuring the change in forearm blood flow before and after blocking flow to the arm for 5 minutes. Blood will be drawn after the test to measure glucose, insulin and fats.

Outcome Measures

Outcome	Result	p-value
PRIMARY Reactive Hyperemic Response After 3 Months of Growth Hormone	21.077	0.644
SECONDARY Glucose	87	0.018 sig
SECONDARY Insulin	11.3	0.04 sig
SECONDARY HOMA	43	0.004 sig
SECONDARY Triglycerides	75	0.804
SECONDARY LDL	110	0.095
SECONDARY HDL	47	0.648

Eligibility Criteria

Inclusion Criteria

isolated growth hormone deficiency (peak growth hormone level less than 10 ng/ml in response to arginine-insulin stimulation with cortisol responses and thyroid function tests), panhypopituitarism with appropriate thyroxine (normal free T4 level) and cortisol replacement (8-12 mg/m2/day) and non classic growth hormone deficiency (growth velocity less than 5 cm/year; peak growth hormone >10 ng/ml).

Exclusion Criteria

Taking medications other than the appropriate hormonal replacement(L-thyroxine, cortisol, estrogen or testosterone, DDAVP)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00373386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.