Cardiovascular DiseasesNCT00005232
Gubbio Study Five-year Follow-up: Lithium Countertransport, Blood Pressure, and Other Variables
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct a five-year follow-up of the population of Gubbio, a town in north central Italy, in order to determine the relationship of baseline sodium-stimulated lithium countertransport to subsequent change in blood pressure and incidence of hypertension. 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
- Aug 1988to Jul 1993
- 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
To conduct a five-year follow-up of the population of Gubbio, a town in north central Italy, in order to determine the relationship of baseline sodium-stimulated lithium countertransport to subsequent change in blood pressure and incidence of hypertension.
Read the detailed description
BACKGROUND:
The field work of the baseline or prevalence phase of the Gubbio Study on the Epidemiology of Hypertension was conducted between March 1983 and December 1985. The population sample included all individuals age 5 and over residing in the town of Gubbio. The survey involved a standardized comprehensive examination focussed on traits previously shown to be related to hypertensive and/or other adult cardiovascular diseases, and on other traits of current concern as possible risk factors. This latter category included measurement of red blood cell electrolyte concentrations and fluxes, particularly sodium-stimulated lithium countertransport. The study was planned, organized, and conducted by the Merck, Sharp and Dohme Center for Epidemiologic Research in cooperation with Gubbio civic and medical leaders, and with laboratory facilities in Gubbio, Naples, and Rome.
Follow-up examinations were conducted in the Centro di Medicina Preventiva in Gubbio which was furnished and equipped by Merck, Sharp and Dohme of Rome, Italy. Additional work was conducted at the Center for Epidemiologic Research of Merck, Sharp and Dohme in Rome, at the University of Naples, and at Northwestern University in Chicago.
DESIGN NARRATIVE:
This prospective study re-examined the 5,500 residents of Gubbio who took part in the Gubbio Population Study in 1983-1985. The data collected on follow-up focused mainly on factors related to change in blood pressure and development of hypertension and included standard physical examination, height, weight, girth, blood pressure, medical history and family medical history, urine collection for study of electrolyte excretion, venipuncture, 12-lead electrocardiogram, m-mode echocardiogram, pulse, skinfold measurement, carbon monoxide content of exhaled breath, sociodemographic data on age, marital status, education, and employment, and life style data on diet, alcohol intake, smoking, and physical activity.
Measurements made at baseline permitted assessment of whether the hypothesized positive relation of lithium countertransport to blood pressure was independent of such factors as age, sex, body mass index, alcohol intake, plasma uric acid, glucose, family history, and other variables generally associated with blood pressure. The relationship between 5-year changes in these factors, change in lithium countertransport, and in blood pressure were also examined. Several additional important unresolved questions on the epidemiology of blood pressure and hypertension were explored: the role of macronutrients and micronutrients in lithium countertransport and its change; red blood cell sodium and potassium concentrations and their relation to blood pressure; possible differences in calcium metabolism between hypertensives and normotensives; genetic polymorphisms related to lipid-lipoprotein metabolism and possible influence on blood pressure; patterns of blood pressure change in the elderly, the 639 and 341 persons age 65-74 and over 75, respectively, at baseline. Coronary heart disease incidence was also studied.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Coronary Disease
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 startAug 1988
- Study completionJul 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005232
- Sponsor's protocol ID
- 1112
- Other IDs
- R01HL040397
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Cirillo M, Laurenzi M. Erythrocyte and platelet volume in human hypertension. The Gubbio Study Collaborative Group. J Hypertens Suppl. 1989 Dec;7(6):S168-9. doi: 10.1097/00004872-198900076-00080.
PubMed 2632707Laurenzi M, Trevisan M. Sodium-lithium countertransport and blood pressure: the Gubbio Population Study. Hypertension. 1989 May;13(5):408-15. doi: 10.1161/01.hyp.13.5.408.
PubMed 2722223Cirillo M, Laurenzi M, Stamler J. Factors related to blood pressure in a sample of Italian children age 5 to 14: the Gubbio Population Study. Semin Nephrol. 1989 Sep;9(3):267-71. No abstract available.
PubMed 2781198Laurenzi M, Stamler R, Trevisan M, Dyer A, Stamler J. Is Italy losing the "Mediterranean advantage?" Report on the Gubbio population study: cardiovascular risk factors at baseline. Gubbio Collaborative Study Group. Prev Med. 1989 Jan;18(1):35-44. doi: 10.1016/0091-7435(89)90052-2.
PubMed 2710761Laurenzi M, Mancini M, Menotti A, Stamler J, Stamler R, Trevisan M, Zanchetti A. Multiple risk factors in hypertension: results from the Gubbio study. J Hypertens Suppl. 1990 Mar;8(1):S7-12. doi: 10.1097/00004872-199003001-00003.
PubMed 2332817Cirillo M, Laurenzi M, Trevisan M, Stamler J. Hematocrit, blood pressure, and hypertension. The Gubbio Population Study. Hypertension. 1992 Sep;20(3):319-26. doi: 10.1161/01.hyp.20.3.319.
PubMed 1516951Laurenzi M, Cirillo M, Trevisan M. The Gubbio data. Epidemiology and pathophysiology. Gubbio Study Research Group. Clin Exp Hypertens A. 1992;14(1-2):261-9. doi: 10.3109/10641969209036187.
PubMed 1541040Trevisan M, Laurenzi M. Correlates of sodium-lithium countertransport. Findings from the Gubbio Epidemiological Study. The Gubbio Collaborative Study Group. Circulation. 1991 Nov;84(5):2011-9. doi: 10.1161/01.cir.84.5.2011.
PubMed 1934375Trevisan M, Krogh V, Cirillo M, Laurenzi M, Dyer A, Stamler J. Red blood cell sodium and potassium concentration and blood pressure. The Gubbio Population Study. Ann Epidemiol. 1995 Jan;5(1):44-51. doi: 10.1016/1047-2797(94)00040-z.
PubMed 7728284Strazzullo P, Cappuccio FP. Hypertension and kidney stones: hypotheses and implications. Semin Nephrol. 1995 Nov;15(6):519-25.
PubMed 8588112Cirillo M, Laurenzi M, Panarelli W, Stamler J. Urinary sodium to potassium ratio and urinary stone disease. The Gubbio Population Study Research Group. Kidney Int. 1994 Oct;46(4):1133-9. doi: 10.1038/ki.1994.376.
PubMed 7861708Schork NJ, Weder AB, Trevisan M, Laurenzi M. The contribution of pleiotropy to blood pressure and body-mass index variation: the Gubbio Study. Am J Hum Genet. 1994 Feb;54(2):361-73.
PubMed 8304351Zanchetti A. Concepts of multiple risk factors management: the Gubbio study. J Hypertens Suppl. 1990 Mar;8(1):S3-5. doi: 10.1097/00004872-199003001-00002.
PubMed 2332815Cirillo M, Laurenzi M, Panarelli W, Trevisan M, Stamler J. Prospective analysis of traits related to 6-year change in sodium-lithium countertransport. Gubbio Population Study Research Group. Hypertension. 1999 Mar;33(3):887-93. doi: 10.1161/01.hyp.33.3.887.
PubMed 10082504Cirillo M, Senigalliesi L, Laurenzi M, Alfieri R, Stamler J, Stamler R, Panarelli W, De Santo NG. Microalbuminuria in nondiabetic adults: relation of blood pressure, body mass index, plasma cholesterol levels, and smoking: The Gubbio Population Study. Arch Intern Med. 1998 Sep 28;158(17):1933-9. doi: 10.1001/archinte.158.17.1933.
PubMed 9759691
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gubbio Study Five-year Follow-up: Lithium Countertransport, Blood Pressure, and Other Variables
- ClinicalTrials.gov ID
- NCT00005232
- Acronym / sponsor ID
- 1112
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 1988
- Study completion
- Jul 1993 (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.
To conduct a five-year follow-up of the population of Gubbio, a town in north central Italy, in order to determine the relationship of baseline sodium-stimulated lithium countertransport to subsequent change in blood pressure and incidence of hypertension.
Detailed description
BACKGROUND:
The field work of the baseline or prevalence phase of the Gubbio Study on the Epidemiology of Hypertension was conducted between March 1983 and December 1985. The population sample included all individuals age 5 and over residing in the town of Gubbio. The survey involved a standardized comprehensive examination focussed on traits previously shown to be related to hypertensive and/or other adult cardiovascular diseases, and on other traits of current concern as possible risk factors. This latter category included measurement of red blood cell electrolyte concentrations and fluxes, particularly sodium-stimulated lithium countertransport. The study was planned, organized, and conducted by the Merck, Sharp and Dohme Center for Epidemiologic Research in cooperation with Gubbio civic and medical leaders, and with laboratory facilities in Gubbio, Naples, and Rome.
Follow-up examinations were conducted in the Centro di Medicina Preventiva in Gubbio which was furnished and equipped by Merck, Sharp and Dohme of Rome, Italy. Additional work was conducted at the Center for Epidemiologic Research of Merck, Sharp and Dohme in Rome, at the University of Naples, and at Northwestern University in Chicago.
DESIGN NARRATIVE:
This prospective study re-examined the 5,500 residents of Gubbio who took part in the Gubbio Population Study in 1983-1985. The data collected on follow-up focused mainly on factors related to change in blood pressure and development of hypertension and included standard physical examination, height, weight, girth, blood pressure, medical history and family medical history, urine collection for study of electrolyte excretion, venipuncture, 12-lead electrocardiogram, m-mode echocardiogram, pulse, skinfold measurement, carbon monoxide content of exhaled breath, sociodemographic data on age, marital status, education, and employment, and life style data on diet, alcohol intake, smoking, and physical activity.
Measurements made at baseline permitted assessment of whether the hypothesized positive relation of lithium countertransport to blood pressure was independent of such factors as age, sex, body mass index, alcohol intake, plasma uric acid, glucose, family history, and other variables generally associated with blood pressure. The relationship between 5-year changes in these factors, change in lithium countertransport, and in blood pressure were also examined. Several additional important unresolved questions on the epidemiology of blood pressure and hypertension were explored: the role of macronutrients and micronutrients in lithium countertransport and its change; red blood cell sodium and potassium concentrations and their relation to blood pressure; possible differences in calcium metabolism between hypertensives and normotensives; genetic polymorphisms related to lipid-lipoprotein metabolism and possible influence on blood pressure; patterns of blood pressure change in the elderly, the 639 and 341 persons age 65-74 and over 75, respectively, at baseline. Coronary heart disease incidence was also studied.
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 16 Mar 2016.
- Background: PubMed 2632707Cirillo M, Laurenzi M. Erythrocyte and platelet volume in human hypertension. The Gubbio Study Collaborative Group. J Hypertens Suppl. 1989 Dec;7(6):S168-9. doi: 10.1097/00004872-198900076-00080.
- Background: PubMed 2722223Laurenzi M, Trevisan M. Sodium-lithium countertransport and blood pressure: the Gubbio Population Study. Hypertension. 1989 May;13(5):408-15. doi: 10.1161/01.hyp.13.5.408.
- Background: PubMed 2781198Cirillo M, Laurenzi M, Stamler J. Factors related to blood pressure in a sample of Italian children age 5 to 14: the Gubbio Population Study. Semin Nephrol. 1989 Sep;9(3):267-71. No abstract available.
- Background: PubMed 2710761Laurenzi M, Stamler R, Trevisan M, Dyer A, Stamler J. Is Italy losing the "Mediterranean advantage?" Report on the Gubbio population study: cardiovascular risk factors at baseline. Gubbio Collaborative Study Group. Prev Med. 1989 Jan;18(1):35-44. doi: 10.1016/0091-7435(89)90052-2.
- Background: PubMed 2332817Laurenzi M, Mancini M, Menotti A, Stamler J, Stamler R, Trevisan M, Zanchetti A. Multiple risk factors in hypertension: results from the Gubbio study. J Hypertens Suppl. 1990 Mar;8(1):S7-12. doi: 10.1097/00004872-199003001-00003.
- Background: PubMed 1516951Cirillo M, Laurenzi M, Trevisan M, Stamler J. Hematocrit, blood pressure, and hypertension. The Gubbio Population Study. Hypertension. 1992 Sep;20(3):319-26. doi: 10.1161/01.hyp.20.3.319.
- Background: PubMed 1541040Laurenzi M, Cirillo M, Trevisan M. The Gubbio data. Epidemiology and pathophysiology. Gubbio Study Research Group. Clin Exp Hypertens A. 1992;14(1-2):261-9. doi: 10.3109/10641969209036187.
- Background: PubMed 1934375Trevisan M, Laurenzi M. Correlates of sodium-lithium countertransport. Findings from the Gubbio Epidemiological Study. The Gubbio Collaborative Study Group. Circulation. 1991 Nov;84(5):2011-9. doi: 10.1161/01.cir.84.5.2011.
- Background: PubMed 7728284Trevisan M, Krogh V, Cirillo M, Laurenzi M, Dyer A, Stamler J. Red blood cell sodium and potassium concentration and blood pressure. The Gubbio Population Study. Ann Epidemiol. 1995 Jan;5(1):44-51. doi: 10.1016/1047-2797(94)00040-z.
- Background: PubMed 8588112Strazzullo P, Cappuccio FP. Hypertension and kidney stones: hypotheses and implications. Semin Nephrol. 1995 Nov;15(6):519-25.
- Background: PubMed 7861708Cirillo M, Laurenzi M, Panarelli W, Stamler J. Urinary sodium to potassium ratio and urinary stone disease. The Gubbio Population Study Research Group. Kidney Int. 1994 Oct;46(4):1133-9. doi: 10.1038/ki.1994.376.
- Background: PubMed 8304351Schork NJ, Weder AB, Trevisan M, Laurenzi M. The contribution of pleiotropy to blood pressure and body-mass index variation: the Gubbio Study. Am J Hum Genet. 1994 Feb;54(2):361-73.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 16 Mar 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 NCT00005232, which also lists 17 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 16 Mar 2016.