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

NCT06638177 | Active Not Recruiting

• 1 other identifier: 2024P001006
• Study Type: observational
• Target: 200,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Herpes Zoster (HZ)

Keywords

shingles; herpes zoster; post-herpetic neuralgia; obesity; plasma metabolomics; observational study

Outcome Measures

Primary Outcomes (1)

• Incident herpes zoster assessed by questionnaire

  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.

  2000-2024

Secondary Outcomes (1)

• Post-herpetic neuralgia assessed by questionnaire

  2000-2024

Study Arms (3)

Health Professionals Follow-Up Study

The HPFS is an ongoing prospective study of 51,529 male health professionals (dentists, veterinarians, pharmacists, optometrists, osteopaths, and podiatrists) who were 40 to 75 years of age at enrollment in 1986. Approximately 97% of participants were of white European descent. Similar to the NHS cohorts, participants have been followed through mailed biennial questionnaires (https://www.hsph.harvard.edu/hpfs/hpfs-questionnaires/) that ascertained medical history, lifestyle, and health-related behaviors, as previously described.88,89 The 2004, 2006, and 2008 questionnaires included questions that elicited information on history of HZ and the year when the episode of HZ occurred. The upcoming 2024 questionnaire will also elicit information on history of HZ, whether participants had been vaccinated against HZ and the date of vaccination.

Nurses Health Study

In 1976, the NHS I enrolled 121,700 female nurses ages 30 to 55 years who returned a mailed questionnaire regarding their medical history and lifestyle.85,86 There were no exclusions by race; 95% were white reflecting the racial make-up of nurses at that time. Participants receive follow-up questionnaires biennially to record newly diagnosed illnesses and to update lifestyle factors and every 4 years received semiquantitative food frequency questionnaires (FFQs).87 The questionnaires (available at https://nurseshealthstudy.org/participants/questionnaires) are administered every other year, and the 40-year follow-up exceeds 90% of eligible person-time. Information on history of HZ and the date at which HZ occurred was collected on the 2000, 2004, 2008, 2012, 2019, 2021 and 2023 biennial questionnaires. The 2021 and 2023 questionnaires also collected information on whether participants had been vaccinated against HZ and the date of vaccination.

Nurses Health Study II

In 1989, 116,430 female registered nurses from 15 states ages 25-42 years completed the initial questionnaire and comprise the NHS II. There were no exclusions by race; 2% were black, 2% Asian, and 2% Hispanic. As in NHS I, participants receive follow-up questionnaires biennially (https://nurseshealthstudy.org/participants/questionnaires) to record newly diagnosed illnesses and to update lifestyle factors and every 4 years received semiquantitative food frequency questionnaires.87 The average follow-up rate over 30 years is \> 90% of eligible person-time. The 2001, 2005, 2013, 2017, 2019, 2021 and 2023 NHS II questionnaires included questions that elicited information on history of HZ and the year when the episode of HZ occurred. The 2017, 2021 and 2023 questionnaires also collected information on whether participants had been vaccinated against HZ and the date of vaccination.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Objective 1a: All participants from the NHS I, NHS II and HPFS (n \~209,000) who were enrolled at baseline and responded to a questionnaire that asked about HZ will be considered for inclusion. Objective 1b: All participants from the NHS I, NHS II and HPFS for whom plasma biomarker information is available will be considered for inclusion (n \> 19,000). Objective 1c: All NHS I and NHS II participants who completed the Zoster Supplemental Questionnaire (ZSQ) and for whom information on metabolomics information is available will be considered for inclusion (n=1,005 to date). Objective 2a: All participants from the NHS I, NHS II and HPFS for whom we have comprehensive information on plasma metabolomics profiles (n \>13,000) will be considered for inclusion. Objective 2b: All NHS I and NHS II participants who completed the ZSQ and for whom information on metabolomics information is available will be considered for inclusion (n=1,005 to date).

You may qualify if:

• 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

You may not qualify if:

• Reported date of HZ occurred before the study baseline
• Date of HZ cannot be determined
• Exposure information not available for the specific analysis

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• GlaxoSmithKline: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

We have already collected blood from participants. The samples have been stored in liquid nitrogen (-130 degrees C).

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic; Obesity

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: June 1, 1976
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share