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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
    Collaborators
    Merck Sharp & Dohme LLC
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    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
    background
    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
    background
    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
    background
    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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