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Sleep Extension for Obesity
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline testing after 4-6 weeks of intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin Sensitivity
Secondary outcome measures
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
1,935 Previous Clinical Trials
2,299,833 Total Patients Enrolled
77 Trials studying Obesity
13,777 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available for potential participants in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research is actively searching for participants who can fulfill the criteria. The trial was first posted on October 29th 2018 and last edited on August 22nd 2022; 40 patients are required at 1 medical site."
Answered by AI
Are octogenarians authorized to participate in this experiment?
"Applicants to this trial must be aged between 18 and 55. Patients below the age of 18 are eligible for 219 different studies, while 665 trials accept patients over 65 years old."
Answered by AI
What are the prerequisites for participating in this clinical experiment?
"This clinical trial is seeking 40 volunteers with obesity aged 18 to 55. Those wishing to participate must meet the following requirements: Body mass index ranging from 30-45 kg/m2 and nightly sleep duration of 6 hours or less."
Answered by AI
How many participants are currently undergoing treatment as part of this trial?
"Affirmative. Clinicaltrials.gov's listing reflects that the trial, initially posted on October 29th 2018, is actively in search of participants to join its research cohort. A total of 40 people are needed at one location."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've been trying for 20+ years to lose weight...fad diets, exercise, lifestyle changes, doctors, weight loss programs, pills, etc. Some methods worked better than others but I have never come close to achieving my goal weight. While I have been able to lose over 100lbs over a 4 year period, I am still struggling, and am, in fact, gaining again. The excess weight is affecting my daily life like it never has before and I need help.
PatientReceived 2+ prior treatments
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