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OpenTrials
Completed

NCT Number: NCT03033121

Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.

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Key information

Conditions

Growth Hormone Treatment

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endocrinology - University of Palermo

Palermo, 90127, Italy

About this study

Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, No 16) or three injections per week (group B, No 16) GH therapy for 12 months.

Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI) were evaluated in the two groups of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Growth hormone deficiency clinically and biochemically demonstrated

Exclusion criteria

  • Children affected by multiple pituitary hormone deficiency or receiving any other kind of hormonal replacement therapy or drug and GHD children with a shorter follow-up

Treatment and study plan

growth hormone

Drug

Primary outcomes

  1. height

    Time frame: 12 months

    height (standard deviation)

  2. weight

    Time frame: 12 months

    weight (kilograms)

  3. body mass index

    Time frame: 12 months

    body mass index (kilograms/m2)

  4. Insulin growth factor-I

    Time frame: 12 months

    insulin growth factor (IGF)-I (ug/L)

  5. glucose

    Time frame: 12 months

    glucose (mmol/l) during oral glucose tolerance test

  6. insulin

    Time frame: 12 months

    insulin (uU/ml) during oral glucose tolerance test

  7. glycated hemoglobin

    Time frame: 12 months

    glycated hemoglobin (%)

  8. ISI Matsuda

    Time frame: 12 months

    Insulin Sensitivity Index

  9. Oral disposition index

    Time frame: 12 months

    Oral Disposition Index (DIo)

  10. Homa IR

    Time frame: 12 months

    The homeostatic model assessment of insulin resistance

  11. LDL cholesterol

    Time frame: 12 months

    Low Density Lipoprotein cholesterol (mmol/l)

  12. Triglycerides

    Time frame: 12 months

    triglycerides (mmol/l)

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

Acronym: GH 3 wk dose

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2017
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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