Environmental Toxicants Avoidance Study (NPETA-GD)

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.

Study Overview

• Status: Suspended
• Conditions: Glucose Intolerance; Pollution; Exposure; Glycemic Control
• Intervention / Treatment: Behavioral: Avoidance Education

Detailed Description

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. Questionnaires including a Medical Symptom Questionnaire, Weekly Stress Inventory and Knowledge Attitudes and Behavior Questionnaire will be administered pre and post-intervention.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kenmore, Washington, United States, 98028-4966
      • Bastyr University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 hemoglobin A1c (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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Avoidance Education; Reduction of environmental toxins exposure from the diet will be achieved by switching to organic foods. Reduction of residential and occupational exposure to toxins from household cleaning products, cosmetics, personal care products, and other sources will be achieved by switching to safer products or avoidance of the toxic exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percentile score of urinary excretion of toxicant marker metabolites pre and post three-week dietary and lifestyle intervention	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in immediate glucose response measured by daily fasting and post-prandial blood glucose measurements.	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 glucose 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

Collaborators and Investigators

• Sponsor: Bastyr University
• Investigators: Principal Investigator: Paola Costa-Mallen, PhD, Bastyr University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: 20-1672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie the results reported in any publications, after deidentification (text, tables, figures and appendices).
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No