More Favorable Metabolic Impact of Three-Times-Weekly versus Daily Growth Hormone Treatment in Naïve GH-Deficient Children.

Alessandro Ciresi, Floriana Cicciò, Stefano Radellini, Valentina Guarnotta, Anna Maria Calcaterra, Carla Giordano
Author Information
  1. Alessandro Ciresi: Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
  2. Floriana Cicciò: Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
  3. Stefano Radellini: Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
  4. Valentina Guarnotta: Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
  5. Anna Maria Calcaterra: Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
  6. Carla Giordano: Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy. ORCID

Abstract

OBJECTIVE: To evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with growth hormone deficiency (GHD).
DESIGN: 32 GHD children (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, 16 patients) or TIW (group B, 16 patients) GHT for 12 months.
METHODS: Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during OGTT, glycosylated hemoglobin (HbA1c), lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), and the insulin sensitivity index (ISI).
RESULTS: After 12 months, both groups showed a significant and comparable improvement in height ( < 0.001) and IGF-I ( < 0.001). As regards the metabolic parameters, in both groups, we found a significant increase in fasting insulin ( < 0.001 and = 0.026) and Homa-IR ( < 0.001 and = 0.019). A significant increase in fasting glucose ( = 0.001) and a decrease in ISI ( < 0.001) and DIo ( = 0.002) were only found in group A.
CONCLUSIONS: The TIW regimen is effective and comparable with the daily regimen in improving auxological parameters and has a more favorable metabolic impact in GHD children. This trial is registered with ClinicalTrials.gov NCT03033121.

Associated Data

ClinicalTrials.gov | NCT03033121

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Word Cloud

Created with Highcharts 10.0.00001<insulin=metabolicchildrenGHDgroupparameterssignificantauxologicalgrowthdaily16patientsTIW12monthsIGF-IglucoseindexDIoHoma-IRISIgroupscomparablefoundincreasefastingregimenOBJECTIVE:evaluatewhethertwodifferentregimensweeklyinjectionsleadsimilareffectshormonedeficiencyDESIGN:3225malesmeanage105±22 yrrandomlyassignedreceiveBGHTMETHODS:Auxologicalinsulin-likefactor-IOGTTglycosylatedhemoglobinHbA1clipidprofileoraldispositionhomeostasismodelassessmentestimateresistancesensitivityRESULTS:showedimprovementheightregards026019decrease002ACONCLUSIONS:effectiveimprovingfavorableimpacttrialregisteredClinicalTrialsgovNCT03033121FavorableMetabolicImpactThree-Times-WeeklyversusDailyGrowthHormoneTreatmentNaïveGH-DeficientChildren

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