Adipocyte Function and Somtropin Deficiency

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Growth Hormone

• Registration Number: NCT01351818
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.

Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2008-01
• Study Completion: 2008-03
• Status Verified: 2011-05
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-10
• Last Update Submitted: 2011-05-10
• Study First Posted: 2011-05-11
• Last Update Posted: 2011-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency
• Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee
• Body Mass Index (BMI) within ±1 SD

Exclusion Criteria

• Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied
• Diabetes mellitus
• Intestinal inflammatory disease
• Celiac disease
• Uncontrolled hyperthyroidism
• AIDS
• Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions
• Chronic liver disease
• Eating disorders: anorexia, bulimia, etc
• Long-term treatment with anti-obesity drugs or drugs causing malabsorption

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Growth hormone	Growth Hormone	Patients with a condition

Primary Outcome Measures

Name	Time	Method
To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion	1 year

Secondary Outcome Measures

Name	Time	Method
Height assessment (using Harpenden stadiometer)	1 year
Weight assessment	1 year
BMI assessment	1 year

Trial Locations

Locations (1)

Investigational site; 🇪🇸 Tenerife, Spain