Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02654262
Status:
UNKNOWN
Last Update Posted:
2016-09-26
First Post:
2016-01-11
Brief Title:
Soft Tissue and Bone Development in Young Girls
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Obesity and Bone Development in Young Girls
Status:
UNKNOWN
Status Verified Date:
2016-09
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:
STAR
Brief Summary:
Obesity during adolescence a critical time for bone development may impair mineral accrual and reduce bone strength leading to greater fracture risk during adolescence and later in life This study seeks to determine the effect of obesity and accompanying metabolic changes insulin resistance and inflammation on bone mineral accrual and related changes in structure and strength in young girls The information is critical to developing effective prevention strategies to counter the linked risks of obesity and osteoporosis both major public health concerns
Detailed Description:
The pediatric obesity epidemic continues unabated Its cardio-metabolic complications are undisputed including inflammation insulin resistance IR glucose intolerance and greater prevalence of type 2 diabetes T2D in youth We contend an equally serious consequence of these obesity co-morbidities is their detrimental effects on bone development during adolescence a critical time for mineral accrual and architectural modeling that underlies bone strength and fracture risk This proposition has received little attention and the sparse results are mixed with reports of augmented and impaired mineralization In contrast animal data demonstrates reduced mineral accrual and compromised architecture with insulin resistance and chronic inflammation The conflicting results in youth are likely due to mixed samples and analyses that commingle obese youth with metabolic complications with so called metabolically healthy obese youth and the use of technology ie dual energy x-ray absorptiometry DXA to measure bone outcomes that is confounded by the very changes that investigators seek to detect We posit that the positive mechanical effect of excess adiposity on bone is countered by chronic low-grade inflammation and IR so that obese youth with these metabolic complications suffer impaired bone development whereas obesity in otherwise metabolically healthy youth augments development A thorough understanding of the effects of adiposity and its co-morbidities on bone development is crucial to the development of efficacious interventions aimed at maximal mineral accrual and bone modeling Thus we propose primary aims designed to clarify the effects of obesity insulin resistance and inflammation on bone around the time of peak height velocity Adipose tissue AT distribution undoubtedly matters especially abdominal visceral AT and skeletal muscle fat content both strongly related to insulin resistance Failure to characterize fat distribution is another important limitation of past studies Consequently we will assess the effect of visceral AT and skeletal muscle fat along with whole body fatness and propose secondary aims designed to develop safe cost effective methods that we and others can use for estimating AT distribution a critical component of risk that has rarely been studied in youth relative to bone development
Primary Aims
1 Assess the associations of total and regional adiposity visceral AT and leg muscle fat content insulin resistance and inflammation with bone mass density structure and strength in normal weight overweight and obese pre-menarcheal girls
2 Assess the effects of total and regional adiposity insulin resistance and inflammation on bone development ie 2 year changes in bone parameters in normal weight and obese pre-menarcheal girls
Primary Aims
1 Assess the associations of total and regional adiposity visceral AT and leg muscle fat content insulin resistance and inflammation with bone mass density structure and strength in normal weight overweight and obese pre-menarcheal girls
2 Assess the effects of total and regional adiposity insulin resistance and inflammation on bone development ie 2 year changes in bone parameters in normal weight and obese pre-menarcheal girls
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