Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120497
Status:
UNKNOWN
Last Update Posted:
2011-07-20
First Post:
2005-07-13
Brief Title:
Study to Examine Insulin Resistance During Growth Hormone Treatment for Short Stature Due to Low Birthweight
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Growth Hormone and Insulin Resistance in Children With Intrauterine Growth Restriction
Status:
UNKNOWN
Status Verified Date:
2011-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRG 2004-0964 | None | None | None |