Gubbio Study Five-year Follow-up: Lithium Countertransport, Blood Pressure, and Other Variables
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005232
First Posted
May 25, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00005232
Brief Title
Gubbio Study Five-year Follow-up: Lithium Countertransport, Blood Pressure, and Other Variables
Study Type
Observational
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
August 1988 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1993 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension, Coronary Disease
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
2632707
Citation
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.
Results Reference
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PubMed Identifier
2722223
Citation
Laurenzi 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.
Results Reference
background
PubMed Identifier
2781198
Citation
Cirillo 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. Erratum In: Semin Nephrol 1990 May;10(3):305.
Results Reference
background
PubMed Identifier
2710761
Citation
Laurenzi 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.
Results Reference
background
PubMed Identifier
2332817
Citation
Laurenzi 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.
Results Reference
background
PubMed Identifier
1516951
Citation
Cirillo 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.
Results Reference
background
PubMed Identifier
1541040
Citation
Laurenzi 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.
Results Reference
background
PubMed Identifier
1934375
Citation
Trevisan 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.
Results Reference
background
PubMed Identifier
7728284
Citation
Trevisan 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.
Results Reference
background
PubMed Identifier
8588112
Citation
Strazzullo P, Cappuccio FP. Hypertension and kidney stones: hypotheses and implications. Semin Nephrol. 1995 Nov;15(6):519-25.
Results Reference
background
PubMed Identifier
7861708
Citation
Cirillo 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.
Results Reference
background
PubMed Identifier
8304351
Citation
Schork 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.
Results Reference
background
PubMed Identifier
2332815
Citation
Zanchetti 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.
Results Reference
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PubMed Identifier
10082504
Citation
Cirillo 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.
Results Reference
background
PubMed Identifier
9759691
Citation
Cirillo 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.
Results Reference
background
PubMed Identifier
9024143
Citation
Laurenzi M, Cirillo M, Panarelli W, Trevisan M, Stamler R, Dyer AR, Stamler J. Baseline sodium-lithium countertransport and 6-year incidence of hypertension. The Gubbio Population Study. Circulation. 1997 Feb 4;95(3):581-7. doi: 10.1161/01.cir.95.3.581.
Results Reference
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PubMed Identifier
8641740
Citation
Cirillo M, Laurenzi M, Panarelli W, Trevisan M, Dyer AR, Stamler R, Stamler J. Sodium-lithium countertransport and blood pressure change over time: the Gubbio study. Hypertension. 1996 Jun;27(6):1305-11. doi: 10.1161/01.hyp.27.6.1305. Erratum In: Hypertension 1996 Nov;28(5):919.
Results Reference
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Gubbio Study Five-year Follow-up: Lithium Countertransport, Blood Pressure, and Other Variables
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