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CPAP + Lifestyle Intervention for Prediabetes (TECH Trial)
N/A
Recruiting
Led By Esra Tasali, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prediabetes
Sleep apnea
Must not have
Diabetic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether adding CPAP treatment to lifestyle intervention can help improve cardiometabolic outcomes in individuals with prediabetes.
Who is the study for?
This trial is for overweight or obese individuals who have prediabetes and sleep apnea. It's not open to those with diabetes, currently in a weight loss program, or with diseases that could shorten life or make the treatments risky.
What is being tested?
The study tests if adding CPAP treatment to lifestyle changes like diet and exercise can better improve heart health and prevent diabetes in people at high risk due to prediabetes than lifestyle changes alone.
What are the potential side effects?
CPAP may cause discomfort, nasal congestion, dry mouth, sore throat, headaches, and minor stomach bloating. Diet and exercise adjustments typically do not cause severe side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with prediabetes.
Select...
I have been diagnosed with sleep apnea.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline 2-hour glucose levels at 6 months
Secondary study objectives
Change from baseline morning blood pressure at 6 months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Lifestyle Plus CPAP InterventionExperimental Treatment2 Interventions
CPAP treatment, diet and exercise.
Group II: Lifestyle InterventionExperimental Treatment1 Intervention
Diet and exercise.
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
839,962 Total Patients Enrolled
15 Trials studying Obesity
1,985 Patients Enrolled for Obesity
Northwestern UniversityOTHER
1,652 Previous Clinical Trials
961,341 Total Patients Enrolled
34 Trials studying Obesity
11,462 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,463 Previous Clinical Trials
4,337,229 Total Patients Enrolled
472 Trials studying Obesity
590,964 Patients Enrolled for Obesity
Esra Tasali, MDPrincipal InvestigatorUniversity of Chicago
6 Previous Clinical Trials
897 Total Patients Enrolled
1 Trials studying Obesity
23 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that could shorten my life or make treatments risky.I have been diagnosed with prediabetes.You are currently in a weight loss program.You are too heavy for this study.I have been diagnosed with sleep apnea.I have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle Plus CPAP Intervention
- Group 2: Lifestyle Intervention
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: NCT04225507 — N/A