Gubbio Study Five-year Follow-up: Lithium Countertransport, Blood Pressure, and Other Variables

March 15, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

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Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1988

Study Completion (Actual)

July 1, 1993

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

June 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112
  • R01HL040397 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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