Avoidance Education for Glucose Intolerance

Phase-Based Estimates
1
Effectiveness
1
Safety
Bastyr University, Kenmore, WA
Glucose Intolerance+2 More
Avoidance Education - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Glucose Intolerance

Study Summary

This study is evaluating whether a diet and lifestyle modification intervention can reduce toxicant burden and improve glucose response.

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Eligible Conditions

  • Glucose Intolerance
  • Pollution; Exposure
  • Glycemic Control

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Avoidance Education will improve 1 primary outcome and 2 secondary outcomes in patients with Glucose Intolerance. Measurement will happen over the course of 3 months.

3 months
Change in immediate glucose response measured by an oral glucose tolerance test (OGTT) pre and post three-week dietary and lifestyle intervention
Change in immediate glucose response measured by daily fasting and post-prandial blood glucose measurements.
Change in percentile score of urinary excretion of toxicant marker metabolites pre and post three-week dietary and lifestyle intervention

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Toxicant avoidance and glucose dysregulation

This trial requires 25 total participants across 2 different treatment groups

This trial involves 2 different treatments. Avoidance Education is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Toxicant avoidance and glucose dysregulation
Behavioral
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Who is running the study

Principal Investigator
E. S.
Erin Sweet, Assistant Clinical Scientist
Bastyr University

Closest Location

Bastyr University - Kenmore, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must be at least 18 years old. show original
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.
You are not already eating a majority organic-food diet and drinking filtered water (>50% by self-disclosure). show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is glucose intolerance?

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Glucose is a sugar-derived energy fuel that is found in foods. There is a body’s capability for using it, and when it must be used (as in exercising), it can cause a high blood sugar level. Glucose intolerance is when an individual has this deficiency and cannot metabolize all the glucose consumed by the body. The condition results in people having high blood sugar levels and, perhaps, even prediabetes.\n

Unverified Answer

What are the signs of glucose intolerance?

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Glucose intolerance does not cause early signs of diabetes. The classic clinical syndromes of insulin insensitivity (e.g. glucose intolerance), impaired glucose regulation and type (2) diabetes do not exist.

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What are common treatments for glucose intolerance?

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This review provides a perspective on the evaluation and treatment of glucose intolerance in the general population. The most popular treatments include pharmacologic agents to lower blood sugar levels (metformin, diet, exercise and supplements), dietary modification, and physical activity. The use of insulin is now more common than in the past. It is recommended that these interventions be prescribed by trained professionals.

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What causes glucose intolerance?

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Metabolic disturbances that affect insulin action (including insulin resistance and defective beta cell function) are significant contributors to the development of glucose intolerance. Some of the genes that influence these disturbances are also likely to contribute to the development of hyperglycemia and hyperinsulinemia.

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How many people get glucose intolerance a year in the United States?

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Approximately 15% of individuals in the USA met GLP-1 threshold at the beginning of the study, an increase from previous studies. The majority of GLP-1 threshold is undetectable after treatment, with lower prevalence in Asians than Hispanics, and higher at younger ages. Although these findings need to be confirmed with a longitudinal study, GLP-1 and GLP-1 receptor should be considered in screening and treatment of glucose intolerance.

Unverified Answer

Has avoidance education proven to be more effective than a placebo?

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Although only the education group has had its blood glucose levels lowered, this improvement is sufficient to warrant an investment in avoidance education in patients with glucose intolerance.

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Who should consider clinical trials for glucose intolerance?

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The high prevalence of the disease and the fact that most therapies are unsatisfactory implies an urgent need for more effective treatments. A large proportion of individuals eligible for clinical trials for glucose intolerance will be lost to enrollment, but a significant number of patients, particularly those with normal glucose tolerance, will be identified and treated with effective therapies by the time available for enrollment.

Unverified Answer

What is the latest research for glucose intolerance?

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Although research findings about the effects of GS on human health can be found widely, there is much inconsistency. Therefore, the most important message to take from the research findings for glucose intolerance is that the key issue is the balance between the benefits of low GCT and the higher costs that may arise when lowering GCT compared with raising postprandial GCT.

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What are the latest developments in avoidance education for therapeutic use?

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The development and implementation of new interventions is hampered by insufficient systematic evidence to date, by methodological problems and by an inadequate assessment of their effects in terms of health. Moreover, the need for an effective and rigorous dissemination of clinical information remains imperative if the prevention of food-related diseases is to be achieved.

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Is avoidance education typically used in combination with any other treatments?

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The research indicates that a high percentage of patients were satisfied with the program of information, but there were no significant differences between the two groups with regard to the percentage of satisfied patients.

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What is the primary cause of glucose intolerance?

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The primary cause of glucose intolerance is pancreatic exocrine insufficiency and not adipose tissue abnormalities. Although both adipose tissue abnormalities and insulin resistance appear in some cases of glucose intolerance, it is usually only the severity of the pancreatic dysfunction alone that predicts the development of insulin resistance, type 2 diabetes, and dyslipidemia.

Unverified Answer
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