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

Not Applicable

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Diagnostic Test: euglycemic hyperinsulinemic clamp

• Registration Number: NCT03525171
• Lead Sponsor: University of Palermo

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2015-12-30
• Study Completion: 2015-12-30
• Study First Submitted: 2017-10-25
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-02
• Last Update Submitted: 2018-05-02
• Study First Posted: 2018-05-15
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	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
GHD children	euglycemic hyperinsulinemic clamp	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

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity in GHD children	baseline and after 12 months of GH treatment	insulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity

Trial Locations

Locations (1)

Endocrinology - University of Palermo; 🇮🇹 Palermo, Italy