Metabolic Impact of Intermittent CPAP (MIIC)

• ClinicalTrials.gov Identifier: NCT02824263
• Recruitment Status: Recruiting
• First Posted: July 6, 2016
• Last Update Posted: September 16, 2019
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to CPAP therapy are enrolled to undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained so that metabolic function can be compared between sleep apnea and CPAP nights.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Device: CPAP withdrawal	Not Applicable

Detailed Description:

Participants with a history of moderate severe sleep apnea (AHI>20) will be enrolled if participants meet inclusion/exclusion criteria. Investigators will report to the sleep laboratory on two nights, (1) after continuing their CPAP or (2) after discontinuing CPAP for 3 nights. The order of observation will be randomized. A standard research dinner is provided before each study. IV's are placed so that blood can be sampled at frequent (30 min) intervals throughout the night. In the morning after each study, a glucose tolerance test and endothelial function study (endoPAT) are performed. Serum samples will be analyzed for glucose, insulin, free fatty acids, triglycerides, hormones, and other metabolic biomarkers.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Metabolic Impact of Intermittent CPAP
• Actual Study Start Date: July 2013
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: CPAP; Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory.
Experimental: CPAP withdrawal; Cessation of established CPAP therapy for 3 nights. CPAP will NOT be worn during this period, and a metabolic sleep study off CPAP is performed in the research laboratory on the third night.	Device: CPAP withdrawal; CPAP is discontinued for 3 nights.

Outcome Measures

Primary Outcome Measures :

1. Change in concentration of Free Fatty Acids (FFA, mmol/L) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]
   Serial samples taken during sleep, 29 time points per night, 2 nights
2. Change in concentration of Glucose (mg/dl) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]
   Serial samples taken during sleep, 29 time points per night, 2 nights
3. Change in concentration of Insulin (mcU/ml) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]
   Serial samples taken during sleep, 29 time points per night, 2 nights
4. Change in concentration of Triglycerides (mg/dl) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]
   Serial samples taken during sleep, 29 time points per night, 2 nights

Secondary Outcome Measures :

1. Serial Oral Glucose Tolerance Test (OGTT) to assess change over time [ Time Frame: 2 nights, <1 month apart, each visit with 5 time points ]
   Serial samples taken in the morning after each sleep study, 5 time points
2. Change in Reactive hyperemia Index (RHI) [ Time Frame: 2 nights, <1 month apart, 1 measurement each visit ]
   Measured in the morning using Itamar EndoPAT device. This will measure the ratio of blood flow after brachial artery occlusion to blood flow prior to brachial artery occlusion. Normal values range from approximately 1 to 3 with higher values being associated with better vascular function.
3. Change in concentration of C-reactive protein (mg/L) [ Time Frame: 2 nights, <1 month apart, 1 measurement each visit ]
   Measured twice (CPAP/no CPAP) in the morning

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)> 10).
• They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.

Exclusion Criteria:

• Uncontrolled hypertension with systolic blood pressure >170 or diastolic blood pressure > 110
• Congestive heart failure
• Use of clonidine or nicotinic acid medication
• Diabetes requiring the use of insulin
• Known pregnancy, by urine testing in women of child-bearing age
• History of falling asleep while driving, near miss
• High risk occupation (pilot, commercial driver)
• Hemoglobin < 10 g/dL on point of care screening

Contacts and Locations

Contacts

Contact: Chenjuan Gu, MD; 410-550-1816; cgu14@jhmi.edu

Contact: Tracy Klopfer; 410-550-2380; tracy.klopfer@jhmi.edu

Locations

United States, Maryland

Johns Hopkins Bayview Medical Center; Recruiting

Baltimore, Maryland, United States, 21224

Contact: Chenjuan Gu 410-550-1816 cgu14@jhmi.edu

Contact: Tracy Klopfer 4105502380 tracy.klopfer@jhmi.edu

Principal Investigator: Jonathan C Jun, MD

Sub-Investigator: Vsevolod Y Polotsky, MD, Ph.D

Sub-Investigator: Alan R Schwartz, MD

Sub-Investigator: Philip L Smith, MD

Sub-Investigator: Susheel Patil, MD, Ph.D

Sub-Investigator: Jason Kirkness, Ph.D

Sub-Investigator: Hartmut Schneider, MD, Ph.D

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Jonathan C Jun, MD; Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chopra S, Rathore A, Younas H, Pham LV, Gu C, Beselman A, Kim IY, Wolfe RR, Perin J, Polotsky VY, Jun JC. Obstructive Sleep Apnea Dynamically Increases Nocturnal Plasma Free Fatty Acids, Glucose, and Cortisol During Sleep. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3172-3181. doi: 10.1210/jc.2017-00619.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02824263
• Other Study ID Numbers: NA_00086830
• First Posted: July 6, 2016
• Last Update Posted: September 16, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Johns Hopkins University:

obstructive sleep apnea; CPAP; metabolism

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases