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Sleep Extension for Obesity
N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Altered glucose metabolism: Fasting glucose ≥100 mg/dL, 2-h plasma glucose ≥140 mg/dL during an oral glucose tolerance test (OGTT), HbA1c ≥5.7%, or homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.5
Be between 18 and 65 years old
Must not have
Significant organ dysfunction/disease (e.g. diabetes, kidney disease)
Prior bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline testing after 4-6 weeks of intervention
Awards & highlights
Summary
This trial will study the effects of extended sleep on glucose metabolism in obese people. Half will be instructed to sleep 8 hours, while the other half maintain their current sleep habits.
Who is the study for?
This trial is for adults with obesity who sleep less than 6 hours a night and have signs of altered glucose metabolism, like high fasting blood sugar or insulin resistance. They should have a BMI between 30-45 kg/m2. People can't join if they consume lots of caffeine or alcohol, are pregnant, exercise intensely, have sleep disorders, had weight loss surgery, use tobacco or drugs, or have serious health issues like diabetes.
What is being tested?
The study tests whether increasing sleep to 8 hours can improve the body's control over blood sugar levels in people with obesity. Participants will be randomly divided into two groups: one will extend their sleeping time while the other continues their usual habits.
What are the potential side effects?
Since this trial involves non-medical intervention (sleep extension), side effects may include changes in mood or alertness due to alterations in sleep patterns but no direct medical side effects are expected from extending sleep alone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood sugar or insulin resistance levels indicate I may have altered glucose metabolism.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a significant health condition like diabetes or kidney disease.
Select...
I have had weight loss surgery in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline testing after 4-6 weeks of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline testing after 4-6 weeks of intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insulin Sensitivity
Secondary study objectives
24 hour cytokine concentrations
24 hour hormone concentrations
24 hour metabolite concentrations
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep ExtensionExperimental Treatment1 Intervention
Extend time-in-bed by one hour
Group II: ControlActive Control1 Intervention
Normal sleep habits \< 7h
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep extension
2019
N/A
~180
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,583 Total Patients Enrolled
81 Trials studying Obesity
14,113 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed sleep disorder.You sleep less than 6 hours per night.I have a significant health condition like diabetes or kidney disease.I have had weight loss surgery in the past.My blood sugar or insulin resistance levels indicate I may have altered glucose metabolism.My blood sugar or insulin resistance levels indicate I may have altered glucose metabolism.Your body mass index is between 30 and 45.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Sleep Extension
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT03594994 — N/A
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