Adipocyte Function and Somtropin Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Growth hormone

Patients with a condition

Growth Hormone

Intervention Type DRUG

Interventions

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Growth Hormone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No