What side effects are associated with this type of intervention?

Common treatments for prediabetes include lifestyle interventions like time-restricted eating (TRE) and pharmacological treatments such as metformin. TRE, which aligns eating patterns with circadian rhythms, generally has minimal side effects but may cause initial hunger or irritability as the body adjusts. Metformin, a widely used medication, can cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Both approaches aim to improve insulin sensitivity and metabolic health, but patients should consult their healthcare provider to tailor the treatment to their individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of prediabetes that directly align with the mechanisms of time-restricted eating (TRE). However, lifestyle interventions, including dietary changes and weight management strategies, are commonly recommended to improve metabolic health and insulin sensitivity in prediabetes. Medications like metformin, which is used for type 2 diabetes, may also be prescribed off-label to help manage prediabetes by improving insulin sensitivity and glycemic control.

What other types of research exist?

Promising novel alternatives to Time-Restricted Eating for prediabetes patients include low-carbohydrate diets, ketogenic diets, intermittent fasting, and pharmacological interventions such as pramlintide. Adjustments in insulin therapy timing based on continuous glucose monitoring also show potential for improving glycemic control.

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Time-Restricted Feeding for Cardiovascular Disease Risk Factors

N/A

Recruiting

Led By Courtney M. Peterson, Ph.D.

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Aged 30-65 years old

Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl

Must not have

Lost or gained more than 3 kg of weight in the past 3 months

Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial is testing whether eating only during certain hours of the day (time-restricted eating) can help people with prediabetes control their blood sugar, lose weight, and improve heart health. Participants will follow different eating schedules for a few months to see which is most effective. Time-restricted eating (TRE) is an emerging dietary intervention for weight loss and metabolic health, with various studies investigating its effects on body weight, fat oxidation, and heart health.

Who is the study for?

This trial is for adults aged 30-65 with a BMI of 27-43 who regularly wake up between 5-8 am and are prediabetic. It's not suitable for those with psychiatric conditions, significant diseases, recent weight fluctuations, or on certain medications affecting glucose or blood pressure.

What is being tested?

The study tests if eating within specific hours (Early TRF: ~8 am-3 pm; Mid-day TRF: ~1 pm - 8 pm) versus a control schedule (~8 am - 8 pm) affects blood sugar control, blood pressure, and cardiovascular risk factors over a period of 10 weeks.

What are the potential side effects?

Since the intervention involves dietary changes rather than medication, side effects may include hunger outside of eating windows, potential temporary changes in energy levels or mood due to adjustment to new eating patterns.

Eligibility Criteria

Inclusion Criteria

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

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I am between 30 and 65 years old.

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My blood sugar levels indicate I am prediabetic.

Exclusion Criteria

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

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I have lost or gained more than 3 kg in the last 3 months.

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I have a sleep disorder or usually sleep less than 6 hours.

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I have a serious stomach or gut condition, had major surgery on it, or have gallstones.

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I have been diagnosed with cancer in the past 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Beta-cell responsivity index (a measure of beta-cell function)

C-Peptide

Glucose AUCs

+6 more

Secondary study objectives

8-isoprostane

Cortisol

Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure

+4 more

Other study objectives

Adherence

Anxiety

Appetite

+18 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Mid-day TREExperimental Treatment1 Intervention

Group II: Early TREExperimental Treatment1 Intervention

Group III: Control SchedulePlacebo Group1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prediabetes include lifestyle modifications such as dietary changes, increased physical activity, and sometimes pharmacological interventions. Dietary changes often focus on reducing calorie intake, improving the quality of consumed carbohydrates, and increasing fiber intake. Time-restricted eating (TRE), a form of intermittent fasting, aligns eating patterns with circadian rhythms, potentially enhancing insulin sensitivity and improving glycemic control. Physical activity helps increase insulin sensitivity and aids in weight management. Pharmacological treatments, like metformin, work by improving insulin sensitivity and reducing glucose production in the liver. These interventions are crucial for prediabetes patients as they can prevent the progression to type 2 diabetes and reduce the risk of associated cardiovascular diseases.

Meal frequency; does it determine postprandial lipaemia?Optimal Dietary Strategies for Prevention of Atherosclerotic Cardiovascular Disease in Diabetes: Evidence and Recommendations.The effect of diurnal distribution of carbohydrates and fat on glycaemic control in humans: a randomized controlled trial.