Clinical trial NCT04821752: Environmental Toxicants Avoidance Study
Official title: Non-Persistent Environmental Toxicants Avoidance Study for Individuals With Glucose Dysregulation Who Are Not Using Insulin (NPETA-GD)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pollution; Exposure
Glucose Intolerance
Glycemic Control
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm trial with rolling enrollment
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in percentile score of urinary excretion of toxicant marker metabolites pre and post three-week dietary and lifestyle intervention
timeFrame: 3 months
Secondary outcomes:
measure: Change in immediate glucose response measured by daily fasting and post-prandial blood glucose measurements.
timeFrame: 3 months
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: Bastyr University
name: Paola Costa-Mallen, PhD
role: PRINCIPAL_INVESTIGATOR
References: