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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | July 1990 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005468 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Lipid Variability--Influence of Stress |
| Official Title ICMJE | |
| Brief Summary | To investigate the variability of lipids and specifically the effects of stress on serum triglyceride levels, total cholesterol, HDL, and LDL in a 2.5 year epidemiological study. |
| Detailed Description | BACKGROUND: While researchers had documented some of the behavioral contributors to fluctuation in individuals' lipid levels (e.g., nutrition patterns, smoking, exercise), little attention had been given to psychosocial stress. Early reports utilizing accountants, race car drivers, and air traffic controllers provided some uncontrolled data associating stress with cholesterol increases. Yet, no empirical research on stress that concomitantly examined other related influences was available. This paucity of data was probably due to lack of objective measures of stress and difficulty in measuring lipid subfractions. DESIGN NARRATIVE: Based on the results of their pilot study, and their research observations, the investigators predicted significant positive associations between stress level and triglycerides. A total of 228 public accountants (148 men and 80 women to provide comparable power between the sexes) were recruited from the greater Birmingham, Alabama area. Participants were evaluated monthly for 18 months, across three stressful and non-stressful work intervals (i.e., tax seasons). The investigators also collected data (during this same time frame) to closely monitor the following variables that affect lipids: dietary intake (including alcohol, caffeine, total calories, total fat, saturated fat, and dietary cholesterol), smoking, and physical activity, and oral contraceptive use, pregnancy status and menstrual stage among the women. Additionally, a substudy presented a unique opportunity for them to investigate the relation between stress and triglyceride-rich lipoproteins in the formation of foam cells. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History, Longitudinal |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | December 1992 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005468 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4913 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | June 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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