Environmental Toxicants Avoidance Study

Glucose Intolerance Clinical Trial

— NPETA-GD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821752
• Other study ID #: 20-1672
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2022
• Source: Bastyr University
• Contact: Amber Coggins
• Phone: 425 602 3000
• Email: acoggins[@]bastyr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Intolerance
• Glycemic Control
• Pollution; Exposure

Intervention

Behavioral:
• Avoidance Education
Dietary modification and lifestyle interventions

Locations

Country	Name	City	State
United States	Bastyr University	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 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