Study to Examine Insulin Resistance During Growth Hormone Treatment for Short Stature Due to Low Birthweight

NCT00120497 | Unknown DMC

• 2 other identifiers: 2005P-000384IRG 2004-0964
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Insulin resistance is common among children with low birthweight. Moreover, growth hormone treatment for ensuing short stature also causes insulin resistance. Our objective is to examine these processes. Insulin resistance has recently been linked to the accumulation of stores of fat in muscle cells which can be measured by MRI. We hypothesize that children who are short due to low birthweight have increased muscle fat stores, but that growth hormone treatment will paradoxically reverse this association. To test this hypothesis, muscle fat stores will be measured in children who are short due to low birthweight before and after receiving growth hormone therapy. Other parameters linked to insulin resistance (glucose tolerance, blood markers, and body composition) will also be assessed. This study may lead to ways to increase growth hormone safety and dose limitations.

Conditions

Fetal Growth Retardation

Keywords

short stature; intrauterine growth restriction; insulin resistance; intramyocellular lipid; small for gestational age; glucose tolerance

Interventions

somatropin (rDNA) DRUG

Dosage form/strength: 13.8 mg powder in 2-chamber cartridge; reconstitutes to 10 mg/ml Dosage regimen: 0.48 mg/kg/week Route/rate of administration: subcutaneous injection, daily dose

Also known as: Genotropin, recombinant human growth hormone

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children, age 6-12 years old, with short stature associated with low birth weight

You may qualify if:

• height \< 5%-ile
• birthweight \< 10%-ile for gestational age
• gestation: ≥ 36 weeks
• male or female
• age: 8-12 years
• BMI = 10-90%-ile
• normal childhood activity, no physical or other limitations
• bone age ≤ 12 years
• 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
• other causes of short stature (e.g., Prader-Willi, intracranial lesions, hypopituitarism, Turner syndrome, GHD, etc.)
• significant systemic disease (pulmonary, cardiac, renal, or other)
• non-removable metal
• other conditions judged by the investigator to pose a hazard (including history of neoplasm)
• simultaneous participation in another medical investigation or trial

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Fetal Growth Retardation; Dwarfism; Insulin Resistance

Interventions

Human Growth Hormone; DNA, Ribosomal; Growth Hormone

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; DNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lynne L Levitsky, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynne L Levitsky, MD

CONTACT

617-726-2909; llevitsky@partners.org

David B Rhoads, PhD

CONTACT

617-724-2707; rhoads@helix.mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2005
• First Posted: July 18, 2005
• Study Start: July 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (1)