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

Comparison Between Euglycemic Hyperinsulinemic Clamp and Surrogate Indexes of Insulin Sensitivity in Children With Growth Hormone Deficiency.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03525171
Acronym
clamp-GHD
Enrollment
23
Registered
2018-05-15
Start date
2014-01-01
Completion date
2015-12-30
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

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.

Interventions

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).

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in insulin sensitivity in GHD childrenbaseline and after 12 months of GH treatmentinsulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026