- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04821752
Environmental Toxicants Avoidance Study (NPETA-GD)
Non-Persistent Environmental Toxicants Avoidance Study for Individuals With Glucose Dysregulation Who Are Not Using Insulin (NPETA-GD)
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Amber Coggins
- Telefonnummer: 3161 425 602 3000
- E-mail: acoggins@bastyr.edu
Undersøgelse Kontakt Backup
- Navn: Kate Elliott
- Telefonnummer: 3118 425 602 3000
- E-mail: kelliott@bastyr.edu
Studiesteder
-
-
Washington
-
Kenmore, Washington, Forenede Stater, 98928
- Rekruttering
- Bastyr University
-
Kontakt:
- Erin Sweet, ND, MPH
- Telefonnummer: 3363 425-602-3000
- E-mail: esweet@bastyr.edu
-
Ledende efterforsker:
- Erin S Sweet, ND, MPH
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years old or older
- Able to complete the remote informed consent process.
- Glucose dysregulation with HbA1c >= 5.7% at baseline
- 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.
- Those not already eating a majority organic-food diet and drinking filtered water (>50% by self-disclosure)
Exclusion Criteria
- Use of insulin or insulin analog medications
- Planning to have elective surgery, diagnostic procedures, dental, or cosmetic procedures during the study period
- Unable or unwilling to modify dietary and lifestyle behaviors
- Those already eating a majority organic-food diet and drinking filtered water (>50% by self-disclosure)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Dietary modification and lifestyle interventions
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Erin Sweet, ND, MPH, Bastyr University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20-1672
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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