NCT01351818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2005

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

2.7 years

First QC Date

May 2, 2011

Last Update Submit

May 10, 2011

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (3)

  • Height assessment (using Harpenden stadiometer)

    1 year

  • Weight assessment

    1 year

  • BMI assessment

    1 year

Study Arms (1)

Growth hormone

Patients with a condition

Drug: Growth Hormone

Interventions

Growth HormoneDRUG
Growth hormone

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with GH deficiency

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Investigational site

Badajoz, Badajoz, Spain

Location

Investigational site

Don Benito, Badajoz, Spain

Location

Investigational site

Cáceres, Cáceres, Spain

Location

Investigational site

Cadiz, Cádiz, Spain

Location

Investigational site

Córdoba, Córdoba, Spain

Location

Investigational site

Granada, Granada, Spain

Location

Investigational site

Huelva, Huelva, Spain

Location

Investigational site

Jaén, Jaen, Spain

Location

Investigational site

Murcia, Murcia, Spain

Location

Investigational site

Málaga, Málaga, Spain

Location

Investigational site

Seville, Sevilla, Spain

Location

Investigational site

Santa Cruz de Tenerife, Tenerife, Spain

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 11, 2011

Study Start

May 1, 2005

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations

ES(12)