Clinical trial
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Active, not recruiting · Not applicable · 0 countries · Registry ID NCT06638177
What this study is about
The investigators' objectives are to examine the longitudinal association of obesity and obesity-related factors and risk of incident herpes zoster (HZ), also known as shingles, and the longitudinal association of obesity and obesity-related factors and risk of developing post-herpetic neuralgia (PHN) among those with HZ. The investigators propose to examine more refined assessments of adiposity, leveraging the resources of several large-scale ongoing cohort studies of women and men with decades of follow-up and rich health-related data, including multiple validated anthropomorphic measures, medical history, dietary intake, and lifestyle factors. The investigators will also examine existing data on plasma adipokines, cytokines, and plasma metabolomics. The investigators will use the Nurses' Health Study (NHS I), Nurses' Health Study II (NHS II), and the Health Professionals Follow-up Study (HPFS) (total N\>200,000) to prospectively investigate whether obesity and obesity-related factors influence the risk of developing HZ. The investigators have already identified \>30,000 cases of incident HZ among the 3 cohorts (reported with high validity) and information on HZ continues to be collected. In addition, the investigators obtained detailed information on HZ course, complications (including PHN), treatment and other related factors on a Zoster Supplemental Questionnaire (ZSQ) administered to those participants in the NHS I and II who reported "shingles" on the main questionnaires (n=10,123 to date). The investigators will also administer the ZSQ to newly identified HZ cases identified on the 2023 NHS I and NHS II biennial questionnaires. No previous study has investigated the longitudinal relation between adiposity and risk of post-herpetic neuralgia (PHN). This study could provide important new insight into how obesity and obesity-related factors influence the risk of HZ, and the risk of developing PHN among individuals with HZ, and how alterations in circulating metabolites and metabolic pathways, including those that are obesity-related, are associated with risk of developing HZ and PHN.
Basic eligibility
Full registry criteria
Treatments and study arms
Primary outcomes
Biennial Questionnaires We have collected information about HZ and date of diagnosis on validated biennial questionnaires in the NHS I, NHS II and HPFS. These questionnaires were completed by over 200,000 participants. Participants were asked about clinician-diagnosed "shingles" and the year of diagnosis. We used the term "shingles" as this is the more commonly used name for HZ and to avoid confusion with other herpes virus infections. Over 30,000 cases of HZ have been reported. The validity of the self-reported HZ information was demonstrated by comparing reports of HZ by questionnaire with medical records in the subset of participants for whom medical records were obtained. Only the first report of HZ will be included for each participant.
Study locations
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