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Meal Timing Modification for Type 2 Diabetes

N/A

Recruiting

Led By Michael Snyder, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 18 years of age or older

Be 18 years of age or older;

Must not have

Use of weight loss medications or specific diets

Major organ disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how different meal times affect people with diabetes and prediabetes, in terms of blood sugar, metabolism, microbiome, and sleep physiology. Additionally, researchers will study how different meals affect a person's temperature and heart rate.

Who is the study for?

This trial is for adults over 18 with prediabetes or type 2 diabetes managed by diet or metformin. Participants should be generally healthy, not pregnant, and not on weight loss meds or special diets. They must understand the study and agree to its procedures.

What is being tested?

The study examines how meal timing and composition affect blood sugar levels, metabolism, gut bacteria, body temperature, heart rate response, and sleep in people with prediabetes or type 2 diabetes.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include hunger at unusual times due to altered eating patterns and potential discomfort from monitoring devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using weight loss medications or following a specific diet.

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I do not have any major organ disease.

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I have had weight loss surgery in the past.

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I am taking diabetes medication other than metformin.

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I am able to understand and follow the study's requirements.

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I have a condition like celiac disease that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in glycemic control as measured by change in blood sugar values.

Core body temperature response to meal consumption

Secondary study objectives

Change in sleep quality measured as duration of sleep stages

Change in sleep quality measured as frequency of sleep stages

Change in wake duration during sleep

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment4 Interventions

Participants will undergo a baseline phase for 20 days, where they will follow their regular dietary intake, physical activity, and sleep. They will be wearing a CGM and an activity monitor and for a couple of nights, they will use a sleep monitor. That will be followed by 4 interventional phases where they will be asked to limit their daily eating to 10 hours or less (Time Restricted Eating, TRE), with the eating window and the caloric distribution will be shifted during each of the next 3 phases, each phase lasting 20 days. The last phase will last 8 days and participants will be asked to consume provided meals with a determined amount of protein, carbohydrates, and fat. Their body temperature will be measured using a continuous temperature device and a heart rate monitor to capture dynamic rage of the sympathetic response during and after the meal consumption (thermotyping).

0 / 8Eligibility criteria met