Fetal Growth RetardationNCT00120497
Study to Examine Insulin Resistance During Growth Hormone Treatment for Short Stature Due to Low Birthweight
An observational study of Fetal Growth Retardation, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- somatropin (rDNA)
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children, age 6-12 years old, with short stature associated with low birth weight
Who may be able to join
- height < 5%-ile
- birthweight < 10%-ile for gestational age
- gestation: ≥ 36 weeks
- male or female
- age: 8-12 years
- BMI = 10-90%-ile
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- normal childhood activity, no physical or other limitations
- bone age ≤ 12 years
- normal, balanced diet (20-40% calories from fat)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
David B Rhoads, PhD, 617-724-2707, rhoads@helix.mgh.harvard.edu
Martin Torriani, MD
About this study
Official title: Growth Hormone and Insulin Resistance in Children With Intrauterine Growth Restriction
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.
Read the detailed description
Growth hormone (GH) is an effective height-enhancing treatment for short stature. One underlying disorder is intrauterine growth restriction (IUGR). Increased growth enhances quality of life as well as improving body composition, metabolism, and lipid distribution. However, both GH therapy and IUGR can cause insulin resistance. Scientists have recently linked insulin resistance to the accumulation of fat inside muscle cells (intramyocellular lipids or IMCL). Although GH generally reduces overall body fat, its effect on IMCL has not yet been examined. This association can be examined in children with IUGR initiating GH treatment for short stature.
Hypothesis: Children with IUGR will have increased IMCL linked to insulin resistance, but GH treatment may paradoxically reverse this association.
Objectives: To assess changes in IMCL during GH therapy and to increase our knowledge of GH action.
Study design: Prepubertal children initiating a course of GH therapy indicated by persistent short stature as a result of IUGR will be recruited to participate in a crossover study.
- IMCL (soleus and tibialis anterior) will be measured non-invasively by proton magnetic resonance spectroscopy (1H-MRS)
- Body composition will be measured by DEXA and morphometry
- Whole body insulin sensitivity (IS) will be assessed by oral glucose tolerance
- Levels of plasma lipids and hormones will be measured
Endpoints: The primary endpoint will be to define the effect of GH on IMCL content in IUGR children. Secondary endpoints will be (i) to compare the relationships between IMCL and IS before and after GH therapy, and (ii) to identify the correlative changes in plasma hormones and metabolites that may underlie the IMCL changes.
Significance: IMCL is anticipated to be a valuable probe for understanding GH effects on glucose homeostasis. This study is intended to reveal strategies for enhancing GH efficacy without compromising IS. New pharmacological approaches to manage GH-induced glucose intolerance would be important in counteracting this limiting factor in GH dosing.
- Conditions
- Fetal Growth Retardation
- Being tested
- somatropin (rDNA)
- Keywords
- short stature, intrauterine growth restriction, insulin resistance, intramyocellular lipid, small for gestational age, glucose tolerance
- Medical subject headings
- Fetal Growth Retardation, Dwarfism, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropin (rDNA)Drug
Also called Genotropin, recombinant human growth hormone
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lynne L Levitsky, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120497
- Sponsor's protocol ID
- 2005P-000384
- Other IDs
- IRG 2004-0964
- Status last verified
- Jul 2011
- First submitted
- 13 Jul 2005
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone and Insulin Resistance in Children With Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT00120497
- Acronym / sponsor ID
- 2005P-000384
- Conditions
- Fetal Growth Retardation
- Keywords
- short stature, intrauterine growth restriction, insulin resistance, intramyocellular lipid, small for gestational age, glucose tolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 18 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Growth hormone (GH) is an effective height-enhancing treatment for short stature. One underlying disorder is intrauterine growth restriction (IUGR). Increased growth enhances quality of life as well as improving body composition, metabolism, and lipid distribution. However, both GH therapy and IUGR can cause insulin resistance. Scientists have recently linked insulin resistance to the accumulation of fat inside muscle cells (intramyocellular lipids or IMCL). Although GH generally reduces overall body fat, its effect on IMCL has not yet been examined. This association can be examined in children with IUGR initiating GH treatment for short stature.
Hypothesis: Children with IUGR will have increased IMCL linked to insulin resistance, but GH treatment may paradoxically reverse this association.
Objectives: To assess changes in IMCL during GH therapy and to increase our knowledge of GH action.
Study design: Prepubertal children initiating a course of GH therapy indicated by persistent short stature as a result of IUGR will be recruited to participate in a crossover study.
- IMCL (soleus and tibialis anterior) will be measured non-invasively by proton magnetic resonance spectroscopy (1H-MRS)
- Body composition will be measured by DEXA and morphometry
- Whole body insulin sensitivity (IS) will be assessed by oral glucose tolerance
- Levels of plasma lipids and hormones will be measured
Endpoints: The primary endpoint will be to define the effect of GH on IMCL content in IUGR children. Secondary endpoints will be (i) to compare the relationships between IMCL and IS before and after GH therapy, and (ii) to identify the correlative changes in plasma hormones and metabolites that may underlie the IMCL changes.
Significance: IMCL is anticipated to be a valuable probe for understanding GH effects on glucose homeostasis. This study is intended to reveal strategies for enhancing GH efficacy without compromising IS. New pharmacological approaches to manage GH-induced glucose intolerance would be important in counteracting this limiting factor in GH dosing.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, age 6-12 years old, with short stature associated with low birth weight
Key inclusion criteria (9 listed)
- height < 5%-ile
- birthweight < 10%-ile for gestational age
- gestation: ≥ 36 weeks
- male or female
- age: 8-12 years
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropin (rDNA)Also: Genotropin, recombinant human growth hormoneDosage 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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne L Levitsky, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynne L Levitsky, MD (617-726-2909, llevitsky@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.