Adipocyte Function and Somtropin Deficiency

Ferring Pharmaceuticals62 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Growth Hormone Deficiency

Interventions

Growth HormoneDRUG

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (12)

Investigational site

Badajoz, Badajoz, Spain

Investigational site

Don Benito, Badajoz, Spain

Investigational site

Cáceres, Cáceres, Spain

Investigational site

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

Height assessment (using Harpenden stadiometer)

Time frame: 1 year

Weight assessment

Time frame: 1 year

BMI assessment

Time frame: 1 year

Data from ClinicalTrials.gov

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