- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03033121
Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children (GH 3 wk dose)
More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children
Study Overview
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Palermo, Italy, 90127
- Endocrinology - University of Palermo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-wk-GH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Growth Hormone Treatment
-
Prof. Eli HershkovitzUnknownGrowth Hormone Treatment
-
University of AarhusAarhus University HospitalUnknownGrowth Hormone Deficiency | Growth Hormone TreatmentDenmark
-
University of MinnesotaRecruitingGrowth Hormone Deficiency | Growth Hormone TreatmentUnited States
-
Northwell HealthRecruitingGrowth | Growth Disorders | Growth Failure | Growth Hormone TreatmentUnited States
-
Pennington Biomedical Research CenterCompletedAging | Growth Hormone Treatment
-
The University of Texas Medical Branch, GalvestonPfizer; United States Department of DefenseCompletedBurns | Growth Hormone TreatmentUnited States
-
University of PalermoCompleted
-
University of AarhusCompletedMetabolic Diseases | Growth Hormone TreatmentDenmark
-
Assaf-Harofeh Medical CenterUnknownGlaucoma | Growth Hormone TreatmentIsrael
-
Assistance Publique - Hôpitaux de ParisCompletedGrowth Hormone TreatmentFrance
Clinical Trials on Growth Hormone
-
The University of Texas Medical Branch, GalvestonCompletedMild Cognitive ImpairmentUnited States
-
University of PennsylvaniaNational Institute on Aging (NIA)TerminatedAging | Hormone DeficiencyUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of WashingtonNational Institute on Aging (NIA)CompletedAging | Mild Cognitive ImpairmentUnited States
-
Massachusetts General HospitalCompleted
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHealthy VolunteersUnited States
-
University of PennsylvaniaCompletedCongestive Heart FailureUnited States
-
Versartis Inc.Completed
-
Rabin Medical CenterPfizerCompleted
-
Massachusetts General HospitalActive, not recruitingObesity | Fatty Liver | Liver Fat | Obesity, Abdominal | Non-Alcoholic Fatty Liver DiseaseUnited States