PAP Therapy for Metabolism Disorder, Lipid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Metabolism Disorder, Lipid+4 More
PAP Therapy - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.

Eligible Conditions

  • Metabolism Disorder, Lipid
  • Obstructive Sleep Apnea (OSA)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 3 months

Up to 3 months
Acute insulin response to glucose
Adipocyte insulin resistance
Free Fatty Acids (FFA) Oxidation Rate
Free fatty acid insulin sensitivity parameter
Free fatty acid rebound slope
Glucose effectiveness
Insulin sensitivity
Lipolysis suppression slope
Whole body lipolysis rate

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

No Intervention (Aim 1) Group
1 of 3
Lifestyle Intervention Only (Aim 2) Group
1 of 3
PAP Therapy and Lifestyle Intervention (Aim 2) Group
1 of 3
Active Control
Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: PAP Therapy · No Placebo Group · N/A

Lifestyle Intervention Only (Aim 2) Group
Behavioral
Experimental Group · 1 Intervention: Lifestyle Counseling Intervention · Intervention Types: Behavioral
PAP Therapy and Lifestyle Intervention (Aim 2) GroupExperimental Group · 2 Interventions: Lifestyle Counseling Intervention, PAP Therapy · Intervention Types: Behavioral, Device
No Intervention (Aim 1) GroupNoIntervention Group · 1 Intervention: No Intervention (Aim 1) Group · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months
Closest Location: University of Miami · Miami, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
1 TrialsResearching Metabolism Disorder, Lipid
621 CompletedClinical Trials

Who is running the clinical trial?

University of MiamiLead Sponsor
780 Previous Clinical Trials
381,662 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,555 Previous Clinical Trials
46,915,089 Total Patients Enrolled
Naresh Punjabi, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
275 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 70 years.
You have the ability to give informed consent.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.