Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005210
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Sex Steroids Obesity and Lipids in Adolescent Females
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
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:
To prospectively explore the relationships of endogenous sex steroid hormones and obesity and their interactions with lipoprotein cholesterol and apolipoprotein levels in nine and ten year old Black and white adolescent girls for five years during puberty
Detailed Description:
BACKGROUND
In 1987 there was growing evidence that androgens particularly when elevated had an unfavorable effect on lipoapo levels tending to lower HDL cholesterol HDLC and raise LDL cholesterol LDLC Previous studies confirmed that although pre-pubertal boys and girls had similar lipoapo levels post-pubertal boys had a higher ratio of LDLCHDLC than girls in part because of their androgen levels Such lipoapo levels had been associated with an increased risk of coronary heart disease There was also evidence that obese girls tended to be hyperandrogenic and thus had unfavorable lipoapo levels and a higher risk of coronary heart disease This study sought to elucidate whether high androgen levels preceded or were a consequence of obesity
DESIGN NARRATIVE
The longitudinal study was ancillary to the National Growth and Health Study NGHS a multicenter study which investigated the occurrence of obesity in Black and white adolescent girls predictors of the transition to the obese state the correlates of the transition and the relationship of the transition to other coronary heart disease risk factors As part of the NGHS participants from the Cincinnati Ohio and Washington DC public and parochial schools received physical examinations with attention to pubertal staging and anthropometric measurements including weight height and skinfold thickness Along with NGHS blood samples additional blood was obtained in years 1 3 and 5 for measurements of lipids lipoprotein cholesterols apolipoproteins A1 A2 and B and sex steroid hormones including plasma total and free testosterone dehydroepiandrosterone sulfate estradiol and testosterone estrogen binding globulin
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
In 1987 there was growing evidence that androgens particularly when elevated had an unfavorable effect on lipoapo levels tending to lower HDL cholesterol HDLC and raise LDL cholesterol LDLC Previous studies confirmed that although pre-pubertal boys and girls had similar lipoapo levels post-pubertal boys had a higher ratio of LDLCHDLC than girls in part because of their androgen levels Such lipoapo levels had been associated with an increased risk of coronary heart disease There was also evidence that obese girls tended to be hyperandrogenic and thus had unfavorable lipoapo levels and a higher risk of coronary heart disease This study sought to elucidate whether high androgen levels preceded or were a consequence of obesity
DESIGN NARRATIVE
The longitudinal study was ancillary to the National Growth and Health Study NGHS a multicenter study which investigated the occurrence of obesity in Black and white adolescent girls predictors of the transition to the obese state the correlates of the transition and the relationship of the transition to other coronary heart disease risk factors As part of the NGHS participants from the Cincinnati Ohio and Washington DC public and parochial schools received physical examinations with attention to pubertal staging and anthropometric measurements including weight height and skinfold thickness Along with NGHS blood samples additional blood was obtained in years 1 3 and 5 for measurements of lipids lipoprotein cholesterols apolipoproteins A1 A2 and B and sex steroid hormones including plasma total and free testosterone dehydroepiandrosterone sulfate estradiol and testosterone estrogen binding globulin
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL038170 | NIH | None | httpsreporternihgovquickSearchR01HL038170 |