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Evalutation of Insulin Sensitivity Through Hyperinsulinemic Clamp in Children With GH Deficiency (clamp-GHD)

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
euglycemic hyperinsulinemic clamp
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Growth Hormone Deficiency

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Isolated idiopathic GH deficiency diagnosed by the auxological and biochemical criteria of the GH Research Society in prepubertal children
  • Prepubertal children

Exclusion Criteria:

  • Children with multiple hormone deficiency
  • Children receiving other hormonal replacement treatment
  • Pubertal children

Sites / Locations

  • Endocrinology - University of Palermo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

GHD children

controls

Arm Description

23 prepubertal children with isolated GHD consecutively admitted to the Section of Endocrinology of the University of Palermo during treated with GH for at least 12 months underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp

12 prepubertal healthy subjects with short stature recruited among children referred for assessment of short stature as a control group at baseline underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp

Outcomes

Primary Outcome Measures

Change in insulin sensitivity in GHD children
insulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity

Secondary Outcome Measures

Full Information

First Posted
October 25, 2017
Last Updated
May 2, 2018
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT03525171
Brief Title
Evalutation of Insulin Sensitivity Through Hyperinsulinemic Clamp in Children With GH Deficiency
Acronym
clamp-GHD
Official Title
Comparison Between Euglycemic Hyperinsulinemic Clamp and Surrogate Indexes of Insulin Sensitivity in Children With Growth Hormone Deficiency.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
December 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels. The investigators aimed to evaluate insulin sensitivity through the euglycemic hyperinsulinemic clamp, considered the gold standard technique, in children affected by growth hormone deficiency and to compare the M-value with the most commonly used surrogate indexes of insulin sensitivity.
Detailed Description
The investigators aimed of this study was to use the hyperinsulinemic clamp to evaluate the impact of GH treatment on insulin-stimulated glucose utilization (M-value) in a group of children affected by GH deficiency and to compare the clamp-derived index with the most commonly used surrogate indexes of insulin sensitivity. In all patients the auxological and metabolic evaluation was performed at baseline and after 12 months of GH treatment, while in controls these evaluations were only performed at baseline. In all children the investigators measured body height, body mass index (BMI) and waist circumference (WC). A blood sample was drawn after an overnight fast for the measurement of glucose, insulin, Hemoglobin A1c (HbA1c) and IGF-I. This sample served as the baseline for the oral glucose tolerance test (OGTT). Blood samples were collected every 30 min for 120 min for glucose and insulin measurements. As surrogate estimates of insulin sensitivity the investigators used the insulin sensitivity index, a composite index derived from the OGTT and validated by Matsuda and DeFronzo (ISI-Matsuda). On a different day, as a gold standard measurement of insulin sensitivity the investigators performed the euglycemic hyperinsulinemic clamp. As other insulin sensitivity markers, the serum levels of adiponectin and resistin after an overnight fast were also measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We prospectively studied 23 prepubertal children with GH deficiency treated with GH for at least 12 months and 12 healthy subjects with short stature, matched for age and pubertal status
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GHD children
Arm Type
Active Comparator
Arm Description
23 prepubertal children with isolated GHD consecutively admitted to the Section of Endocrinology of the University of Palermo during treated with GH for at least 12 months underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp
Arm Title
controls
Arm Type
Placebo Comparator
Arm Description
12 prepubertal healthy subjects with short stature recruited among children referred for assessment of short stature as a control group at baseline underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp
Intervention Type
Diagnostic Test
Intervention Name(s)
euglycemic hyperinsulinemic clamp
Intervention Description
In addition to auxological and baseline biochemical parameters, we performed the clamp to evaluate insulin sensitivity (M-value) at baseline (GHD group and controls) and after 12 months of GH treatment (GHD group).
Primary Outcome Measure Information:
Title
Change in insulin sensitivity in GHD children
Description
insulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity
Time Frame
baseline and after 12 months of GH treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Isolated idiopathic GH deficiency diagnosed by the auxological and biochemical criteria of the GH Research Society in prepubertal children Prepubertal children Exclusion Criteria: Children with multiple hormone deficiency Children receiving other hormonal replacement treatment Pubertal children
Facility Information:
Facility Name
Endocrinology - University of Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data available on request, to expand and contine the study

Learn more about this trial

Evalutation of Insulin Sensitivity Through Hyperinsulinemic Clamp in Children With GH Deficiency

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