Analysis of Sex Hormones and Lipoproteins in Young Males
Primary Purpose
Cardiovascular Diseases, Atherosclerosis, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037453
First Posted
May 16, 2002
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00037453
Brief Title
Analysis of Sex Hormones and Lipoproteins in Young Males
Study Type
Observational
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 (HD/HL18281), 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 predicts/leads to decreases in HDL-C and increases in LDL-C, apo B, and the LDL-C/HDL-C ratio in adolescent males; (2) increasing E2 predicts decreases in apo B, LDL-C and the LDL-C/HDL- 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- C/HDL-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Atherosclerosis, Heart Diseases
7. Study Design
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Barton
Organizational Affiliation
Maryland Medical Research Institute
12. IPD Sharing Statement
Citations:
PubMed Identifier
12838191
Citation
Morrison JA, Barton BA, Biro FM, Sprecher DL. Sex hormones and the changes in adolescent male lipids: longitudinal studies in a biracial cohort. J Pediatr. 2003 Jun;142(6):637-42. doi: 10.1067/mpd.2003.246.
Results Reference
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Analysis of Sex Hormones and Lipoproteins in Young Males
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