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Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children (GH 3 wk dose)

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ClinicalTrials.gov Identifier: NCT03033121
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Carla Giordano, University of Palermo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Growth Hormone Treatment Drug: Growth Hormone Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children
Study Start Date : January 1, 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Active Comparator: group A
Sixteen growth hormone (GH) deficiency children were assigned to receive daily growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.
Drug: Growth Hormone
Active Comparator: group B
Sixteen growth hormone (GH) deficiency children were assigned to receive three time weekly growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.
Drug: Growth Hormone



Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033121


Locations
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Italy
Endocrinology - University of Palermo
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carla Giordano, Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT03033121    
Other Study ID Numbers: 3-wk-GH
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carla Giordano, University of Palermo:
growth hormone
children
metabolism
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs