Precision Diets for Diabetes Prevention

Study Overview
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Brief Summary
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With this study the investigators want to understand the physiological differences for people developing pre-diabetes and diabetes. The investigators hypothesize that different individuals go through different paths in the development of the disease. By understanding the personal mechanism for developing disease, the investigators will find a personalized approach to prevent that development. The investigators are also hoping to be able to find a biomarker that will pinpoint to the particular defect and thus, diagnose the problem at an earlier stage and have the information to give personalized diet recommendations to prevent the development of diabetes more effectively.

Official Title
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Precision Diets for Diabetes Prevention

Conditions
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Pre Diabetes, Insulin Resistance

Intervention / Treatment
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* Other: Dietary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years of age or older; Not be pregnant, if female; Exclusion Criteria: Have major organ disease, hypertension defined as >160/100, pregnant/lactating, diabetogenic medications, malabsorptive disorders like celiac sprue, others, heavy alcohol use, use of weight loss medications or specific diets, weight change > 2 kg in the last three weeks, history of bariatric surgery. Any medical condition that physicians believe would interfere with study participation or evaluation of results. Mental incapacity a nd/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Optimizing Diet for Glycemic Control<br>All individuals will go through all the phases of the study. Phase 1: Metabolic testing to determine insulin resistance status. Phase 2: Participants follow their own diet while using the CGM (continuous glucose monitor). Participants are provided with 5-10 standardized foods to test during this phase. Phase 3: Participants are provided with additional standardized foods and counseled to continue their own diet during this phase. Phase 4: Participants are counseled on reducing or limiting the foods that caused glucose spikes and they are also counseled on macronutrient composition of their diet based on lipid profile. Participants use the CGM for another cycle of 2-3 weeks to assess effectiveness of the recommendations. Blood is drawn for analyses before and after this cycle. | Other: Dietary<br>* Dietary counseling based on results of CGM analyses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control as measured by change blood sugar values | Change in glycemic control measured from baseline through all phases of study. Glycemic control is derived from continuous glucose monitor (CGM) data and expressed in milligrams/deciliter. | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of blood sugar level as a measurement of maximum peak serum glucose. | Measured from baseline through all phases of the study. | Three years |