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Analysis of Sex Hormones and Lipoproteins in Young Males

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037453
First Posted: May 17, 2002
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To analyze the relationship of sex hormones to lipoproteins in young males.

Condition
Cardiovascular Diseases Atherosclerosis Heart Diseases

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 2001
Study Completion Date: March 2003
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037453


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Bruce Barton Maryland Medical Research Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00037453     History of Changes
Other Study ID Numbers: 1172
R03HL065728 ( U.S. NIH Grant/Contract )
First Submitted: May 16, 2002
First Posted: May 17, 2002
Last Update Posted: March 16, 2016
Last Verified: August 2004

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases