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Behavioral Intervention

Intervention Group for Insulin Sensitivity

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Age: 18-45 years old; equal numbers of men and women

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.

Awards & highlights

Study Summary

This trial aims to find out how increasing the amount of time spent in bed can affect the levels of certain substances in the blood and how well the body responds to insulin. Participants will be randomly assigned to

Who is the study for?

This trial is for people who are overweight or obese, sleep less than 6.5 hours a night, and may have issues with insulin sensitivity. It's not suitable for individuals with certain allergies, eating disorders, or other conditions that could interfere with the study.Check my eligibility

What is being tested?

The study tests if sleeping more (2 extra hours per night) can change blood levels of ceramides (fats) and improve how the body uses insulin compared to just getting healthy lifestyle advice without added sleep.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like increasing sleep duration and providing health information, significant side effects are not expected. However, changes in sleep patterns can sometimes affect mood and alertness.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ analyzed as change from baseline for each week of the ~8 week experimental segment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~analyzed as change from baseline for each week of the ~8 week experimental segment

This trial's timeline: 3 weeks for screening, Varies for treatment, and analyzed as change from baseline for each week of the ~8 week experimental segment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insulin Sensitivity

Total Plasma Ceramides

Secondary outcome measures

Average (per week) daytime alertness change from baseline

Average (per week) nightly total sleep time (change from baseline)

Average (per week) sleep satisfaction change from baseline

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Sleep extension-based intervention focused on increasing time in bed by 2 hours per night.

Group II: Control GroupActive Control1 Intervention

Provided with general health information on diet and physical activity.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,831 Total Patients Enrolled

2 Trials studying Insulin Sensitivity

40 Patients Enrolled for Insulin Sensitivity

Frequently Asked Questions

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

Is the enrollment process currently open for this ongoing medical study?

"As per the information provided on clinicaltrials.gov, this particular clinical trial is not currently accepting new participants. The initial posting of this study was made on December 1st, 2023, and it was last updated on December 21st, 2023. However, please note that there are presently a total of 2067 other ongoing clinical trials actively recruiting participants."

Answered by AI

Which individuals meet the eligibility criteria to be enrolled in this research study?

"In order to meet the eligibility criteria for this research study, individuals must have obesity and fall within the age range of 18 to 45. The clinical trial aims to recruit approximately 70 participants."

Answered by AI

Is the age criterion inclusive of individuals who have reached or surpassed 80 years?

"To participate in this clinical trial, individuals must be within the age range of 18 to 45 years old. It is worth noting that there are a total of 342 trials available for participants under the age of 18 and 1370 trials targeted towards patients over the age of 65."

Answered by AI

What are the specific goals and objectives of this research study?

"The primary objective of this clinical trial is to assess the impact of the intervention on Total Plasma Ceramides levels immediately following its administration. Secondary outcomes include measuring changes in Average (per week) sleep satisfaction from baseline using a 5-point Likert scale recorded in daily sleep logs (1 = very good; 5 = very poor), evaluating changes in Average (per week) nightly total sleep time compared to baseline using wrist-actigraphy, and examining alterations in the timing of food intake by assessing the time at which 50% of daily caloric intake occurs through picture-based food diaries. The average per week will be calculated based on"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Sleep Extension on Ceramides in People With Overweight and Obesity

Christopher Depner 2024. "Effect of Sleep Extension on Ceramides in People With Overweight and Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06180837.

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