Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Environmental Toxicants Avoidance Study (NPETA-GD)

26. juli 2022 oppdatert av: Erin Sweet, Bastyr University

Non-Persistent Environmental Toxicants Avoidance Study for Individuals With Glucose Dysregulation Who Are Not Using Insulin (NPETA-GD)

This study is designed to test whether non-persistent environmental chemicals (PECs) are elevated in people with glucose dysregulation. The primary aim is to measure whether this toxicant burden can be reduced using a dietary and lifestyle modification intervention. The secondary aim is to observe any changes in glucose response pre and post-intervention.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The primary aim will be measured using a commercially-available screening test for urinary toxicant metabolites. The toxicant burden will be measured by a percentile score of each metabolite and summing all percentile values. A risk level of each metabolite will be normalized by the percentile score in order to calculate the total toxic burden for an individual. Wilcoxon-ranked sum non-parametric calculations will be used to evaluate whether pre and post-intervention reduction has occurred. Because this is a single-arm trial, any reduction in the toxicant burden will be correlated with the relative improvement of the secondary endpoint and will be measured using Kendall's tau-beta ranked correlation.

The secondary aim will assess each participant's fasting and post-prandial glucose response measured daily for throughout the 3-week trial.. Because this study is not powered, the estimated man reduction from baseline cannot be estimated. Any reduction in blood glucose mean values will allow us to calculate an effect size for future investigation. The ranking of the improvement in glucose response (AUC) will be tested by ranking the reduction of the toxic burden by a correlation analysis using Kendall's tau-beta ranked correlation described above.

Each participant is provided with a baseline in-person assessment, one midpoint education session and a final assessment session. Each participant will receive a standardized packet of information regarding dietary and lifestyle interventions which reduce toxicant exposures along with a water filter for home use and gift card to support the purchase of organic food during the trial. Questionnaries including a Medical Symptom Questionnaire, Weekly Stress Inventory and Knowledge Atttitudes and Behavior Questionnaire will be administered pre and post-intervention.

Studietype

Intervensjonell

Registrering (Forventet)

25

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Washington
      • Kenmore, Washington, Forente stater, 98928
        • Rekruttering
        • Bastyr University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Erin S Sweet, ND, MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. 18 years old or older
  2. Able to complete the remote informed consent process.
  3. Glucose dysregulation with HbA1c >= 5.7% at baseline
  4. If HgA1c is greater than 6.5% and the potential participant is not already receiving standard care for diabetes from a physician, participants must see their primary care provider for diabetes standard care before enrollment in the study.
  5. Those not already eating a majority organic-food diet and drinking filtered water (>50% by self-disclosure)

Exclusion Criteria

  1. Use of insulin or insulin analog medications
  2. Planning to have elective surgery, diagnostic procedures, dental, or cosmetic procedures during the study period
  3. Unable or unwilling to modify dietary and lifestyle behaviors
  4. Those already eating a majority organic-food diet and drinking filtered water (>50% by self-disclosure)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Toxicant avoidance and glucose dysregulation
To investigate whether or not the excretion of urinary toxicant metabolites is reduced by dietary modification and lifestyle intervention in people with glucose dysregulation; whether the participant's ranked glucose dysregulation correlates with the amount and/or type of toxic metabolites excreted at baseline; and whether the body's immediate response to glucose is improved by the reduction of toxicant burden.
Atferdsmessig: Avoidance Education
Dietary modification and lifestyle interventions

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in percentile score of urinary excretion of toxicant marker metabolites pre and post three-week dietary and lifestyle intervention
Tidsramme: 3 months
The primary aim will be measured using a commercially-available screening test for urinary toxicant metabolites. The toxicant burden will be measured by a percentile score of each metabolite and summing all percentile values. A risk level of each metabolite will be normalized by the percentile score in order to calculate the total toxic burden for an individual. Wilcoxon-ranked sum non-parametric calculations will be used to evaluate whether pre and post-intervention reduction has occurred. Because this is a single-arm trial, any reduction in the toxicant burden will be correlated with the relative improvement of the secondary endpoint and will be measured using Kendall's tau-beta ranked correlation.
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in immediate glucose response measured by daily fasting and post-prandial blood glucose measurements.
Tidsramme: 3 months
A secondary endpoint is to observe each participant's glucose response throughout the 3-week trial period. Because this is not powered, the estimated mean reduction from the baseline to the ending of the trial cannot be estimated. Any reduction in the blood glucsoe mean values allows us to calculate the effect size for future investigation. The ranking of the improvement in glucose response (smaller AUC) is tested with the ranking of the reduction of toxic burden by a correlation analysis described the above.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bastyr University

Etterforskere

  • Hovedetterforsker: Erin Sweet, ND, MPH, Bastyr University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2022

Primær fullføring (Forventet)

1. september 2023

Studiet fullført (Forventet)

1. september 2024

Datoer for studieregistrering

Først innsendt

22. mars 2021

Først innsendt som oppfylte QC-kriteriene

25. mars 2021

Først lagt ut (Faktiske)

30. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juli 2022

Sist bekreftet

1. juli 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20-1672

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Individual participant data that underlie the results reported in any pubilcations, after deidentification (text, tables, figures and appendices).

IPD-delingstidsramme

Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

Tilgangskriterier for IPD-deling

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact esweet@bastyr.edu.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Avoidance Education

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in China

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere