NCT00121875

Brief Summary

Growth hormone treatment improves body fat distribution but also causes insulin resistance. Scientists have recently linked insulin resistance with special stores of fat in the muscles, which can be measured by magnetic resonance imaging (MRI). The researchers hypothesize that growth hormone will paradoxically reverse the linkage between muscle fat stores and insulin resistance. To assess this association and to investigate the cause(s), the researchers will measure muscle fat stores during growth hormone treatment. Other parameters linked to insulin resistance (glucose tolerance, blood markers, and body composition) will also be assessed. This study may lead to improved strategies for monitoring growth hormone therapy.

Trial Health

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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

First QC Date

July 14, 2005

Last Update Submit

September 28, 2009

Conditions

Turner SyndromeIdiopathic Short Stature

Keywords

short statureinsulin resistancebody compositionTurner syndromeintramyocellular lipidglucose tolerance

Outcome Measures

Primary Outcomes (1)

  • to compare the effect of GH on IMCL content in the two subject groups (Turner syndrome vs. ISS)

    3 months

Secondary Outcomes (2)

  • to assess the relationship of IMCL to IR-associated plasma markers in each groups

    3 months

  • to assess the relationship of IMCL to the effect of GH therapy in each groups

    3 months

Study Arms (2)

Turner syndrome

Girls, aged 7-14, with short stature due to Turner syndrome and eligible for growth hormone therapy

Drug: somatropin (rDNA)

Control / idiopathic short stature

Girls, aged 7-14, with idiopathic short stature and eligible for growth hormone therapy

Drug: somatropin (rDNA)

Interventions

somatropin (rDNA)DRUG

Form/Strength: 10 mg aqueous suspension; 5 mg/ml Dosage/Frequency: 0.35 mg/kg/week, daily divided doses Duration: 6 months with 3-month washout period

Also known as: recombinant human growth hormone, Nutropin-AQ
Control / idiopathic short statureTurner syndrome

Eligibility Criteria

Age7 Years - 14 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Girls, age 7-14 years, with short stature due to Turner syndrome or with idiopathic short stature

You may qualify if:

  • Girls, with Turner syndrome or ISS; height standard deviation score (SDS) ≤ -2
  • Bone age ≤ 12 years
  • Normal birthweight
  • Body mass index (BMI) = 10th-90th percentile
  • Normal childhood activity; no physical or other limitations
  • Normal, balanced diet (20-40% calories from fat)

You may not qualify if:

  • Puberty (beyond Tanner Stage 1)
  • Diabetes in subject or first degree relative
  • Sex steroid therapy
  • Chronic conditions requiring medication (treatment for hypothyroidism is permissible)
  • Significant systemic disease (pulmonary, cardiac, renal, or other)
  • Non-removable metal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Turner SyndromeDwarfismInsulin Resistance

Interventions

Human Growth HormoneDNA, RibosomalGrowth Hormone

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDNANucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Lynne L Levitsky, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2005

First Posted

July 21, 2005

Study Start

June 1, 2005

Study Completion

December 1, 2008

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations

US(1)