Epidemic Hypertension in Nigerian Workers
|First Received Date ICMJE||May 25, 2000|
|Last Updated Date||June 23, 2005|
|Start Date ICMJE||January 1991|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005333 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Epidemic Hypertension in Nigerian Workers|
|Official Title ICMJE||Not Provided|
Originally from 1991 to 1991, to test the hypothesis that differences in hypertension prevalence in Nigerian workers were primarily related to differences in socioeconomic status (SES). At renewal in 1996, to determine the importance of weight gain and weight-related factors in blood pressure.
This dynamic population provided a valuable opportunity to gain important information about the etiology of hypertension which would be much more difficult to gain from a United States Black population because higher weight and blood pressure are already entrenched and static in the United States population.
From 1991 to 1996, a cross-sectional study was conducted to test the hypothesis that differences in hypertension prevalence were primarily related to differences in SES. The higher prevalence of hypertension among the high SES Nigerian professionals was thought to be related to higher weight, caloric intake, Westernization of diet, alcohol intake, sodium intake, cardiovascular reactivity, and stress due to job, migration, and change in SES, and to reduced potassium intake and physical activity. Civil servants were systematically sampled from civil service employee lists. Data were collected on blood pressure; urinary sodium, potassium, and protein; diet; anthropometry; electrocardiogram; serum insulin; stress in the work environment, migration history, and cardiovascular reactivity.
In FY 1992, the Office of Research on Women's Health provided supplemental funds to enlarge the study and to perform gender analyses. The supplemental funds were used to determine whether fatty acid distributions, and their relationships to cardiovascular risk factors differed between Nigerian women and United States Black women; United States Black women and United States white women; and Nigerian women and Nigerian men. Forty men and forty women, ages 18 to 30, were chosen randomly from the Nigerian civil servant population. Subjects with hypertension, those using oral contraceptives, or any medication affecting the sympathetic nervous system, were excluded. The Nigerian subjects were compared with 40 Black and 40 white healthy female volunteers at the University of Pittsburgh.
The grant was renewed in 1996 through August 2001 to conduct a longitudinal study of 726 members of the original cohort. The purpose was to determine the importance of weight gain and weight-related factors, and the possible interaction of other factors, e.g. psychosocial, electrolytes, reactivity, macronutrient intake, to change in blood pressure. Factors related to weight gain were identified. The high prevalence of the electrocardiogram left ventricular hypertrophy (ECG-LVH) was validated against echocardiographic measures (ECHO-LVH). Predictors of change in ECG-LVH, and the correlates of microalbuminuria were identified. In Year 2 (Cohort Year 4) half of the population was restudied with echocardiography, cardiovascular reactivity, and new psychosocial measures. In Year 4 (Cohort Year 6), with the exception of cardiovascular reactivity, the full cohort was re-examined for baseline measures, including multiple blood pressure readings, height, weight, waist, hips, ECG, physical activity, two 24 hour dietary recalls, alcohol intake, menopausal status, psychosocial measures, 24 hour urine for sodium, potassium, creatinine, micro-albuminuria, and fasting serum for lipids, insulin, glucose, and creatinine.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Natural History|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||August 2001|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
No eligibility criteria
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00005333|
|Other Study ID Numbers ICMJE||4188|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||August 2004|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP