Adipocyte Function and Somtropin Deficiency (FAYDS)

Ferring

Status: Completed

Conditions: Growth Hormone Deficiency

Treatments: Drug: Growth Hormone

Study type: Observational

Funder types: Industry

Identifiers

NCT01351818

FER-SOM-2004-01

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

62 participants in 1 patient group

Growth hormone

Description:

Patients with a condition

Treatment:

Drug: Growth Hormone