Adipocyte Function and Somtropin Deficiency

The Fayds Project: Adipocyte Function and Somtropin Deficiency

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01351818

Acronym

FAYDS

Enrollment

Registered

2011-05-11

Start date

2005-05-31

Completion date

2008-03-31

Last updated

2011-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

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.

Interventions

DRUGGrowth Hormone

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 12 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Height assessment (using Harpenden stadiometer)	1 year
Weight assessment	1 year
BMI assessment	1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026