Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037453
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2002-05-16
Brief Title:
Analysis of Sex Hormones and Lipoproteins in Young Males
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:
2004-08
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 analyze the relationship of sex hormones to lipoproteins in young males
Detailed Description:
BACKGROUND
The investigators conducted a secondary analysis of the Sex Hormones and Lipoproteins in Adolescent Males Study HDHL18281 a 3-year 1984-1987 study of lipids blood pressure weight fat patterning and sex steroid hormones SSH in adolescent males A total of 664 black and white males ages 10-15 were enrolled into a study designed as a series of repeated data collections over two years within age cohorts Cross-sectional analyses were used to explain differences during adolescence in sex steroid hormones and sex steroid hormone-lipid relationships between black and white boys and between boys with and without a family history of coronary heart disease When the data were originally collected for this study theoretical models of flexible longitudinal analytic techniques had been developed but were not available for computer use These techniques now supported by software allow a more powerful and complete analysis of these data
DESIGN NARRATIVE
The primary aim of these analyses was to explain the contribution of changes in sex steroid hormones and fat patterning to changes in plasma concentrations of high HDL-C and low LDL-C density lipoprotein cholesterol triglycerides TG and apolipoproteins apo Al All and B occurring during puberty in males Sex steroid hormones assayed included estradiol E2 and free testosterone T The following hypotheses were tested 1 increasing free T predictsleads to decreases in HDL-C and increases in LDL-C apo B and the LDL-CHDL-C ratio in adolescent males 2 increasing E2 predicts decreases in apo B LDL-C and the LDL-CHDL- C ratio but the resultant effects will vary with adiposity and fat patterning 3 rapid weight gain predicts increased central adiposity defined as the ratio of truncal skinfolds to total skinfolds and with greater decreases in HDL-C and increases in triglycerides apo B LDL-C and the LDL- CHDL-C ratio Rapid weight gain predicts increased E2 but the atherogenic effects of increased central adiposity on lipids are greater than the anti- atherogenic effects of E2 These analyses provided a better understanding of metabolic factors underlying obesity-hormone-lipoprotein relationships
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The investigators conducted a secondary analysis of the Sex Hormones and Lipoproteins in Adolescent Males Study HDHL18281 a 3-year 1984-1987 study of lipids blood pressure weight fat patterning and sex steroid hormones SSH in adolescent males A total of 664 black and white males ages 10-15 were enrolled into a study designed as a series of repeated data collections over two years within age cohorts Cross-sectional analyses were used to explain differences during adolescence in sex steroid hormones and sex steroid hormone-lipid relationships between black and white boys and between boys with and without a family history of coronary heart disease When the data were originally collected for this study theoretical models of flexible longitudinal analytic techniques had been developed but were not available for computer use These techniques now supported by software allow a more powerful and complete analysis of these data
DESIGN NARRATIVE
The primary aim of these analyses was to explain the contribution of changes in sex steroid hormones and fat patterning to changes in plasma concentrations of high HDL-C and low LDL-C density lipoprotein cholesterol triglycerides TG and apolipoproteins apo Al All and B occurring during puberty in males Sex steroid hormones assayed included estradiol E2 and free testosterone T The following hypotheses were tested 1 increasing free T predictsleads to decreases in HDL-C and increases in LDL-C apo B and the LDL-CHDL-C ratio in adolescent males 2 increasing E2 predicts decreases in apo B LDL-C and the LDL-CHDL- C ratio but the resultant effects will vary with adiposity and fat patterning 3 rapid weight gain predicts increased central adiposity defined as the ratio of truncal skinfolds to total skinfolds and with greater decreases in HDL-C and increases in triglycerides apo B LDL-C and the LDL- CHDL-C ratio Rapid weight gain predicts increased E2 but the atherogenic effects of increased central adiposity on lipids are greater than the anti- atherogenic effects of E2 These analyses provided a better understanding of metabolic factors underlying obesity-hormone-lipoprotein relationships
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 |
|---|---|---|---|
| R03HL065728 | NIH | None | httpsreporternihgovquickSearchR03HL065728 |