Environmental Toxicants Avoidance Study

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04821752
Study type	Interventional
Source	Bastyr University
Contact	Amber Coggins
Phone	425 602 3000
Email	acoggins@bastyr.edu
Status	Recruiting
Phase	N/A
Start date	May 1, 2022
Completion date	September 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05544266` - Rare and Atypical Diabetes Network
Completed	`NCT03241121` - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome	N/A
Completed	`NCT03809182` - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.	Phase 4
Completed	`NCT03675360` - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial	N/A
Completed	`NCT01671293` - Multicomponent Telecare Model for Supporting Prediabetes Patients	N/A
Not yet recruiting	`NCT01402362` - Prevalence of Glucose Intolerance and Risk Factors in Ethiopian Immigrants in Israel; Follow-up Study.	N/A
Completed	`NCT00740363` - Sitagliptin in Renal Transplant Recipients	Phase 4
Completed	`NCT00436475` - Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes	Phase 1/Phase 2
Completed	`NCT04090788` - The Effect of Momordica Charantia Supplementation on Blood Glucose Levels	N/A
Active, not recruiting	`NCT05460884` - Effects of Seaweed Extract on Postprandial Response to White Bread	N/A
Not yet recruiting	`NCT05462834` - Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing	N/A
Completed	`NCT03348020` - Iron and Insulin Resistance in Overweight and Obese Humans	N/A
Terminated	`NCT03356873` - Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX)	N/A
Completed	`NCT03922685` - Effects of Diet and Exercise on Circadian Glycemia	N/A
Completed	`NCT03730727` - Exercise-meal Timing and Postprandial Glucose Control	N/A
Completed	`NCT04743960` - Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition	N/A
Completed	`NCT04004273` - Diabetes, Exercise and Liver Fat (DELIVER)	N/A
Completed	`NCT02412995` - The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite	Phase 0
Terminated	`NCT01887691` - Sleep Effectiveness and Insulin and Glucose Homeostasis	Phase 1
Not yet recruiting	`NCT01436448` - Probiotics (Lactobacillus Rhamnosus) in Reducing Glucose Intolerance During and After Pregnancy	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Environmental Toxicants Avoidance Study — NPETA-GD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms