What is the mechanism of action of this treatment?

Improving sleep quality and duration is essential for maintaining optimal glucose metabolism in healthy subjects. Treatments often focus on behavioral interventions such as sleep hygiene education, cognitive-behavioral therapy for insomnia (CBT-I), and lifestyle modifications including regular physical activity and a balanced diet. These interventions help regulate circadian rhythms and enhance insulin sensitivity, thereby improving the body's ability to manage blood sugar levels. This is particularly important for healthy subjects as it helps prevent the onset of metabolic disorders such as type 2 diabetes and supports overall metabolic health.

What side effects are associated with this type of intervention?

Common pharmacological treatments for improving sleep quality and duration include melatonin agonists like tasimelteon and ramelteon, which can cause headaches, elevated liver function tests, and abnormal dreams. Over-the-counter sleep aids such as diphenhydramine and doxylamine may lead to drowsiness, dry mouth, and constipation. Behavioral interventions like cognitive behavioral therapy for insomnia (CBT-I) generally have no adverse effects but require consistent effort and time commitment from the patient.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving sleep quality and duration, which can indirectly enhance glucose metabolism. Medications such as zolpidem (Ambien), eszopiclone (Lunesta), and suvorexant (Belsomra) are commonly prescribed for insomnia and other sleep disorders. These drugs help regulate sleep patterns, which is crucial for maintaining metabolic health, including glucose metabolism. Improved sleep has been shown to positively affect insulin sensitivity and glucose regulation, thereby reducing the risk of type 2 diabetes and other metabolic disorders.

What other types of research exist?

Promising novel alternatives for improving sleep quality and duration to enhance glucose metabolism in healthy subjects include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has been effective in improving sleep patterns and metabolic health. 2) Use of wearable sleep trackers and apps that provide personalized feedback and interventions to improve sleep hygiene. 3) Implementation of scheduled naps and strategic use of light exposure to regulate circadian rhythms. 4) Dietary interventions, such as time-restricted eating, which align eating patterns with circadian rhythms to improve sleep and metabolic outcomes. 5) Physical activity, particularly morning exercise, which has been shown to improve sleep quality and glucose metabolism.

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Effects of Insufficient Sleep on Sugar Response

N/A

Waitlist Available

Led By Josiane L. Broussard, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Healthy, lean participants

Be between 18 and 65 years old

Must not have

Current or history of any clinically significant medical, psychiatric, or sleep disorder

Use or history of any drugs, medications, supplements, caffeine, and alcohol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one week

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how lack of sleep affects the body's ability to process sugar. Participants will have their sleep reduced to 5 hours per night for several nights. The study targets people who can't get enough sleep to help develop treatments for them.

Who is the study for?

This trial is for healthy, lean individuals who don't exercise regularly and have a consistent sleep pattern of 7-9.25 hours per night. They must live at or above Denver's altitude for 3 months before the study and maintain a strict bedtime schedule for one week prior to starting.

What is being tested?

The study investigates how insufficient sleep affects the body's response to sugar, which could inform treatments for those unable to get adequate sleep due to various reasons.

What are the potential side effects?

Since this trial involves inducing sleep deprivation rather than testing a drug, side effects may include tiredness, mood changes, difficulty concentrating, and potential long-term health impacts if such patterns are sustained.

Eligibility Criteria

Inclusion Criteria

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

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I am healthy and not overweight.

Exclusion Criteria

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

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I have a significant health, mental, or sleep issue.

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I have used drugs, medications, supplements, caffeine, or alcohol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week 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 insulin sensitivity

Secondary study objectives

Changes in circadian rhythms

Changes in cognitive abilities

Changes in macrovascular function

+2 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: Insufficient sleepExperimental Treatment1 Intervention

Each participant will receive 4 nights of insufficient sleep.

0 / 3Eligibility 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

Improving sleep quality and duration is essential for maintaining optimal glucose metabolism in healthy subjects. Treatments often focus on behavioral interventions such as sleep hygiene education, cognitive-behavioral therapy for insomnia (CBT-I), and lifestyle modifications including regular physical activity and a balanced diet. These interventions help regulate circadian rhythms and enhance insulin sensitivity, thereby improving the body's ability to manage blood sugar levels. This is particularly important for healthy subjects as it helps prevent the onset of metabolic disorders such as type 2 diabetes and supports overall metabolic health.

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