Active — Not RecruitingNot Applicable

Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia

200,000 participantsStarted 1976-06

Plain-language summary

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.

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant in the NHS I, NHS II or HPFS cohort studies (n \~290,000) * Provided information on weight and height at least one time * Responded to at least one biennial questionnaire that included questions about HZ * For the analyses examining obesity and risk of PHN, only participants in NHS I and NHS II who completed the ZSQ will be included Exclusion Criteria: * Reported date of HZ occurred before the study baseline * Date of HZ cannot be determined * Exposure information not available for the specific analysis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incident herpes zoster assessed by questionnaire

Timeframe: 2000-2024

Trial details

NCT IDNCT06638177

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Herpes Zoster (HZ) trials