Cardiovascular DiseasesNCT00005333
Epidemic Hypertension in Nigerian Workers
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1991to Aug 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the detailed description
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1991
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Clareann Bunker, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005333
- Sponsor's protocol ID
- 4188
- Other IDs
- R01HL044413
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Evans RW, Bunker CH, Ukoli FA, Kuller LH. Lipoprotein (a) distribution in a Nigerian population. Ethn Health. 1997 Mar-Jun;2(1-2):47-58. doi: 10.1080/13557858.1997.9961814.
PubMed 9395588Yeh LL, Kuller LH, Bunker CH, Ukoli FA, Huston SL, Terrell DF. The role of socioeconomic status and serum fatty acids in the relationship between intake of animal foods and cardiovascular risk factors. Ann Epidemiol. 1996 Jul;6(4):290-8. doi: 10.1016/s1047-2797(96)00023-3.
PubMed 8876839Bunker CH, Ukoli FA, Okoro FI, Olomu AB, Kriska AM, Huston SL, Markovic N, Kuller LH. Correlates of serum lipids in a lean black population. Atherosclerosis. 1996 Jun;123(1-2):215-25. doi: 10.1016/0021-9150(96)05810-8.
PubMed 8782852Markovic N, Matthews KA, Huston SL, Egbagbe E, Ukoli FA, Bunker CH. Blood pressure reactivity to stress varies by hypertensive status and sex in Nigerians. Am J Epidemiol. 1995 Nov 15;142(10):1020-8. doi: 10.1093/oxfordjournals.aje.a117554.
PubMed 7485046Bunker CH, Ukoli FA, Matthews KA, Kriska AM, Huston SL, Kuller LH. Weight threshold and blood pressure in a lean black population. Hypertension. 1995 Oct;26(4):616-23. doi: 10.1161/01.hyp.26.4.616.
PubMed 7558221Ukoli FA, Bunker CH, Fabio A, Olomu AB, Egbagbe EE, Kuller LH. Body fat distribution and other anthropometric blood pressure correlates in a Nigerian urban elderly population. Cent Afr J Med. 1995 May;41(5):154-61.
PubMed 7628000Markovic N, Olomu IN, Bunker CH, Huston SL, Ukoli FA, Kuller LH. Adequacy of a single visit for classification of hypertensive status in a Nigerian civil servant population. Int J Epidemiol. 1994 Aug;23(4):723-9. doi: 10.1093/ije/23.4.723.
PubMed 8002185Huston SL, Bunker CH, Ukoli FA, Rautaharju PM, Kuller LH. Electrocardiographic left ventricular hypertrophy by five criteria among civil servants in Benin City, Nigeria: prevalence and correlates. Int J Cardiol. 1999 Jul 1;70(1):1-14. doi: 10.1016/s0167-5273(99)00061-3.
PubMed 10402040Markovic N, Bunker CH, Ukoli FA, Kuller LH. John Henryism and blood pressure among Nigerian civil servants. J Epidemiol Community Health. 1998 Mar;52(3):186-90. doi: 10.1136/jech.52.3.186.
PubMed 9616424Desai PP, Bunker CH, Ukoli FA, Kamboh MI. Genetic variation in the apolipoprotein D gene among African blacks and its significance in lipid metabolism. Atherosclerosis. 2002 Aug;163(2):329-38. doi: 10.1016/s0021-9150(02)00012-6.
PubMed 12052480Forrest KY, Bunker CH, Kriska AM, Ukoli FA, Huston SL, Markovic N. Physical activity and cardiovascular risk factors in a developing population. Med Sci Sports Exerc. 2001 Sep;33(9):1598-604. doi: 10.1097/00005768-200109000-00025.
PubMed 11528351
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemic Hypertension in Nigerian Workers
- ClinicalTrials.gov ID
- NCT00005333
- Acronym / sponsor ID
- 4188
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1991
- Study completion
- Aug 2001 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
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 design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 9395588Evans RW, Bunker CH, Ukoli FA, Kuller LH. Lipoprotein (a) distribution in a Nigerian population. Ethn Health. 1997 Mar-Jun;2(1-2):47-58. doi: 10.1080/13557858.1997.9961814.
- Background: PubMed 8876839Yeh LL, Kuller LH, Bunker CH, Ukoli FA, Huston SL, Terrell DF. The role of socioeconomic status and serum fatty acids in the relationship between intake of animal foods and cardiovascular risk factors. Ann Epidemiol. 1996 Jul;6(4):290-8. doi: 10.1016/s1047-2797(96)00023-3.
- Background: PubMed 8782852Bunker CH, Ukoli FA, Okoro FI, Olomu AB, Kriska AM, Huston SL, Markovic N, Kuller LH. Correlates of serum lipids in a lean black population. Atherosclerosis. 1996 Jun;123(1-2):215-25. doi: 10.1016/0021-9150(96)05810-8.
- Background: PubMed 7485046Markovic N, Matthews KA, Huston SL, Egbagbe E, Ukoli FA, Bunker CH. Blood pressure reactivity to stress varies by hypertensive status and sex in Nigerians. Am J Epidemiol. 1995 Nov 15;142(10):1020-8. doi: 10.1093/oxfordjournals.aje.a117554.
- Background: PubMed 7558221Bunker CH, Ukoli FA, Matthews KA, Kriska AM, Huston SL, Kuller LH. Weight threshold and blood pressure in a lean black population. Hypertension. 1995 Oct;26(4):616-23. doi: 10.1161/01.hyp.26.4.616.
- Background: PubMed 7628000Ukoli FA, Bunker CH, Fabio A, Olomu AB, Egbagbe EE, Kuller LH. Body fat distribution and other anthropometric blood pressure correlates in a Nigerian urban elderly population. Cent Afr J Med. 1995 May;41(5):154-61.
- Background: PubMed 8002185Markovic N, Olomu IN, Bunker CH, Huston SL, Ukoli FA, Kuller LH. Adequacy of a single visit for classification of hypertensive status in a Nigerian civil servant population. Int J Epidemiol. 1994 Aug;23(4):723-9. doi: 10.1093/ije/23.4.723.
- Background: PubMed 10402040Huston SL, Bunker CH, Ukoli FA, Rautaharju PM, Kuller LH. Electrocardiographic left ventricular hypertrophy by five criteria among civil servants in Benin City, Nigeria: prevalence and correlates. Int J Cardiol. 1999 Jul 1;70(1):1-14. doi: 10.1016/s0167-5273(99)00061-3.
- Background: PubMed 9616424Markovic N, Bunker CH, Ukoli FA, Kuller LH. John Henryism and blood pressure among Nigerian civil servants. J Epidemiol Community Health. 1998 Mar;52(3):186-90. doi: 10.1136/jech.52.3.186.
- Background: PubMed 12052480Desai PP, Bunker CH, Ukoli FA, Kamboh MI. Genetic variation in the apolipoprotein D gene among African blacks and its significance in lipid metabolism. Atherosclerosis. 2002 Aug;163(2):329-38. doi: 10.1016/s0021-9150(02)00012-6.
- Background: PubMed 11528351Forrest KY, Bunker CH, Kriska AM, Ukoli FA, Huston SL, Markovic N. Physical activity and cardiovascular risk factors in a developing population. Med Sci Sports Exerc. 2001 Sep;33(9):1598-604. doi: 10.1097/00005768-200109000-00025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clareann Bunker
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005333, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016; AzTrials last refreshed its copy on 3 Nov 2026.