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

NCT03525171 | Completed

• 1 other identifier: clamp-GHD
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity in GHD children

  insulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity

  baseline and after 12 months of GH treatment

Study Arms (2)

GHD children

ACTIVE COMPARATOR

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

Diagnostic Test: euglycemic hyperinsulinemic clamp

controls

PLACEBO COMPARATOR

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

Diagnostic Test: euglycemic hyperinsulinemic clamp

Interventions

euglycemic hyperinsulinemic clamp DIAGNOSTIC_TEST

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).

GHD children; controls

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Endocrinology - University of Palermo

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principa Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: May 15, 2018
• Study Start: January 1, 2014
• Primary Completion: December 30, 2015
• Study Completion: December 30, 2015
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

IT (1)