Turner SyndromeNCT00121875
Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature
An observational study of Turner Syndrome and Idiopathic Short Stature, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 14 years, women only
- Conditions the study is for
- Turner Syndrome, Idiopathic Short Stature
- What is being tested?
- somatropin (rDNA)
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Dec 2008
- 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 7 to 14 years
- Women only
- No healthy volunteers
- Child
Study population: Girls, age 7-14 years, with short stature due to Turner syndrome or with idiopathic short stature
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Growth Hormone and Insulin Resistance in Girls With Turner Syndrome or Idiopathic Short Stature
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.
Read the detailed description
Growth hormone (GH) treatment can cause insulin resistance (IR) despite its overall favorable influence on body fat composition. IR is associated with special stores of fat in the muscle (intramyocellular lipid or IMCL), which can be measured by MRI. The researchers hypothesize that changes in IR during GH treatment will be associated with a predictable, but possibly contradictory, change in muscle fat stores. Girls receiving GH for short stature, due to Turner syndrome or idiopathic short stature (ISS), will be studied both during and without GH treatment to assess the impact of GH treatment on muscle fat stores.
Hypothesis: Girls with Turner syndrome will have increased IMCL, corresponding to their insulin resistance, when compared to girls with ISS. GH treatment may paradoxically reverse this association in girls with Turner syndrome.
Objectives: The objectives are to assess changes in IMCL during GH therapy and to increase the researchers' knowledge of GH action.
Study Design: Prepubertal girls receiving GH therapy for short stature due to Turner syndrome or ISS will be recruited to participate in a crossover study. Subjects will be studied twice: first during GH treatment and at baseline, following washout without GH for 3 months. GH treatment for up to 6 months will be provided for eligible girls not currently receiving GH. Assessments include:
- IMCL (soleus and tibialis anterior) measured non-invasively by proton magnetic resonance spectroscopy (1H-MRS)
- Body composition measured by DEXA and morphometry
- Whole body insulin sensitivity assessed by oral glucose tolerance
- Levels of plasma lipids and hormones
Endpoints: The primary endpoint is to define the effect of GH on IMCL content in girls with Turner syndrome versus girls with ISS. The secondary endpoint is to examine how GH affects IMCL content by identifying correlative changes in plasma hormones and metabolites.
Significance: This study is intended to find improved strategies for monitoring GH therapy. In addition, IMCL is anticipated to be a valuable probe for understanding GH effects on glucose homeostasis.
- Conditions
- Turner Syndrome, Idiopathic Short Stature
- Being tested
- somatropin (rDNA)
- Keywords
- short stature, insulin resistance, body composition, Turner syndrome, intramyocellular lipid, glucose tolerance
- Medical subject headings
- Turner Syndrome, 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 recombinant human growth hormone, Nutropin-AQ
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
| Study group | Role | What they receive |
|---|---|---|
| Turner syndrome | Girls, aged 7-14, with short stature due to Turner syndrome and eligible for growth hormone therapy Receives: Drug: somatropin (rDNA) | |
| Control / idiopathic short stature | Girls, aged 7-14, with idiopathic short stature and eligible for growth hormone therapy Receives: Drug: somatropin (rDNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the effect of GH on IMCL content in the two subject groups (Turner syndrome vs. ISS)
Measured: 3 months
Secondary outcomes (2)
to assess the relationship of IMCL to IR-associated plasma markers in each groups
Measured: 3 months
to assess the relationship of IMCL to the effect of GH therapy in each groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJun 2005
- Study completionDec 2008
Why it stopped: Enrollment was too low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
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
- NCT00121875
- Sponsor's protocol ID
- 2004P-002800
- Other IDs
- L3452n
- Status last verified
- Sep 2009
- First submitted
- 14 Jul 2005
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone and Insulin Resistance in Girls With Turner Syndrome or Idiopathic Short Stature
- ClinicalTrials.gov ID
- NCT00121875
- Acronym / sponsor ID
- 2004P-002800
- Conditions
- Turner Syndrome, Idiopathic Short Stature
- Keywords
- short stature, insulin resistance, body composition, Turner syndrome, intramyocellular lipid, glucose tolerance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment was too low.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Dec 2008 (actual)
- First posted
- 21 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.
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.
Detailed description
Growth hormone (GH) treatment can cause insulin resistance (IR) despite its overall favorable influence on body fat composition. IR is associated with special stores of fat in the muscle (intramyocellular lipid or IMCL), which can be measured by MRI. The researchers hypothesize that changes in IR during GH treatment will be associated with a predictable, but possibly contradictory, change in muscle fat stores. Girls receiving GH for short stature, due to Turner syndrome or idiopathic short stature (ISS), will be studied both during and without GH treatment to assess the impact of GH treatment on muscle fat stores.
Hypothesis: Girls with Turner syndrome will have increased IMCL, corresponding to their insulin resistance, when compared to girls with ISS. GH treatment may paradoxically reverse this association in girls with Turner syndrome.
Objectives: The objectives are to assess changes in IMCL during GH therapy and to increase the researchers' knowledge of GH action.
Study Design: Prepubertal girls receiving GH therapy for short stature due to Turner syndrome or ISS will be recruited to participate in a crossover study. Subjects will be studied twice: first during GH treatment and at baseline, following washout without GH for 3 months. GH treatment for up to 6 months will be provided for eligible girls not currently receiving GH. Assessments include:
- IMCL (soleus and tibialis anterior) measured non-invasively by proton magnetic resonance spectroscopy (1H-MRS)
- Body composition measured by DEXA and morphometry
- Whole body insulin sensitivity assessed by oral glucose tolerance
- Levels of plasma lipids and hormones
Endpoints: The primary endpoint is to define the effect of GH on IMCL content in girls with Turner syndrome versus girls with ISS. The secondary endpoint is to examine how GH affects IMCL content by identifying correlative changes in plasma hormones and metabolites.
Significance: This study is intended to find improved strategies for monitoring GH therapy. In addition, IMCL is anticipated to be a valuable probe for understanding GH effects on glucose homeostasis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turner syndrome | – | Drug: somatropin (rDNA)Girls, aged 7-14, with short stature due to Turner syndrome and eligible for growth hormone therapy |
| Control / idiopathic short stature | – | Drug: somatropin (rDNA)Girls, aged 7-14, with idiopathic short stature and eligible for growth hormone therapy |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Girls, age 7-14 years, with short stature due to Turner syndrome or with idiopathic short stature
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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: recombinant human growth hormone, Nutropin-AQForm/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 | Drug | Control / idiopathic short stature, Turner syndrome |
Primary outcome
to compare the effect of GH on IMCL content in the two subject groups (Turner syndrome vs. ISS)
Time frame: 3 months
2 secondary outcomes
to assess the relationship of IMCL to IR-associated plasma markers in each groups
Time frame: 3 months
to assess the relationship of IMCL to the effect of GH therapy in each groups
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Enrollment was too low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2009.
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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 Turner Syndrome and Idiopathic Short Stature, 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Sep 2009. 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?
The study was stopped early (reason given: Enrollment was too low.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the effect of GH on IMCL content in the two subject groups (Turner syndrome vs. ISS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 29 Sep 2009.