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

October 25, 2017 updated by: Carla Giordano, University of Palermo

More Favorable Metabolic Impact of 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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Palermo, Italy, 90127
        • Endocrinology - University of Palermo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height
Time Frame: 12 months
height (standard deviation)
12 months
weight
Time Frame: 12 months
weight (kilograms)
12 months
body mass index
Time Frame: 12 months
body mass index (kilograms/m2)
12 months
Insulin growth factor-I
Time Frame: 12 months
insulin growth factor (IGF)-I (ug/L)
12 months
glucose
Time Frame: 12 months
glucose (mmol/l) during oral glucose tolerance test
12 months
insulin
Time Frame: 12 months
insulin (uU/ml) during oral glucose tolerance test
12 months
glycated hemoglobin
Time Frame: 12 months
glycated hemoglobin (%)
12 months
ISI Matsuda
Time Frame: 12 months
Insulin Sensitivity Index
12 months
Oral disposition index
Time Frame: 12 months
Oral Disposition Index (DIo)
12 months
Homa IR
Time Frame: 12 months
The homeostatic model assessment of insulin resistance
12 months
LDL cholesterol
Time Frame: 12 months
Low Density Lipoprotein cholesterol (mmol/l)
12 months
Triglycerides
Time Frame: 12 months
triglycerides (mmol/l)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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