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Study for Promotion of Health in Recycling Lead

Study for Promotion of Health in Recycling Lead

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02243904
Acronym
SPHERL
Enrollment
270
Registered
2014-09-18
Start date
2015-08-31
Completion date
2024-12-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occupational Exposure

Keywords

Autonomic nervous function, Blood pressure, Cardiovascular regulation, Lead, Occupational exposure, Renal function

Brief summary

Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up study of lead workers with exposure levels varying between and within individuals. SPHERL addresses to what extent between-subject differences or within-subject changes in lead exposure may have a measurable impact on blood pressure, the cardiovascular system, renal function, the autonomic nervous system, peripheral nervous conduction velocity, and neurocognitive function. At the beginning of December 2015, 70 participants were included in the study.

Detailed description

Background * Whether low-level lead exposure impacts on blood pressure, regulation of the cardiovascular system, glomerular or tubular renal function, sympathetic nervous modulation, peripheral nervous conduction velocity, and neurocognitive function remains uncertain. Study Population * SPHERL will enroll 500 lead recycling workers with changing lead exposure, who will be examined at baseline (2014-2015) and followed up at annual intervals for 2 years (2016-2017). Methods * Volunteers eligible for the study are (i) new and existing hires without previous occupational lead exposure who will be performing tasks with or without occupational lead exposure and (ii) existing hires with occupational lead exposure who will be transitioning to job tasks without occupational lead exposure within the next 2 years. * Blood lead concentration will be the main biomarker of exposure. * The main outcome variables are (i) blood pressure measured conventionally and by ambulatory monitoring, and analyzed as continuous or categorical variable, both cross-sectionally and longitudinally; (ii) indexes of glomerular and tubular renal function, (iii) heart rate variability analyzed in the frequency domain as measure of autonomous sympathetic modulation, (iv) peripheral nerve conductivity, (v) neurocognitive performance, (vi) and quality of life \[the EuroQOL five dimensions (EQ-5D) questionnaire\]. Expected Outcomes * Assuming a 4-fold or higher surge in the blood lead concentration, the study is powered to demonstrate over 2 years an acceleration in the age-related rise of systolic blood pressure by 1 to 4 mm Hg or an increase of the coefficient of multiple determination (R2) from 0.22 to 0.24 by adding the change in the blood lead concentration to models relating changes in blood pressure to three other covariables. The longitudinal design of our study complies with the temporality principle of the Bradford-Hill criteria for assessing possible causality between outcomes and exposure.

Interventions

None listed

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Women and men are eligible. * New hires without previous occupational lead exposure who will be performing tasks with lead exposure or current employees without previous occupational lead exposure moving to tasks with exposure. * Informed written consent.

Exclusion criteria

* Pregnancy. * Any serious health condition.

Design outcomes

Primary

MeasureTime frame
Annual change in systolic blood pressure as measured by 24-h ambulatory monitoringBaseline, 1 year and 2 years

Secondary

MeasureTime frameDescription
Annual change in heart functionBaseline, 1 year and 2 yearsAnnual changes in ECG-derived indexes
Annual change in renal functionBaseline, 1 year and 2 yearsAnnual changes in glomerular and tubular renal function measured on a continuous scale and the incidence of renal dysfunction
Annual change in autonomic nervous functionBaseline, 1 year and 2 yearsAnnual changes in alterations in the autonomic nervous cardiovascular modulation, as assessed by heart rate variability
Annual change in central hemodynamicsBaseline, 1 year and 2 yearsAnnual changes in the central hemodynamics, including aortic blood pressure, the central systolic augmentation index, and aortic pulse wave velocity
Annual change in neurocognitive performanceBaseline, 1 year and 2 yearsAnnual changes in neurocognitive testing
Annual change in quality of lifeBaseline, 1 year and 2 yearsAnnual changes in self-assessed quality of life
Annual change in peripheral nervous conduction velocityBaseline, 1 year and 2 yearsAnnual changes in nerve conduction velocity

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026