Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

NCT01156116 | Completed Results DMC

• 1 other identifier: 09-249-A
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.

Conditions

Diabetes; Sleep Apnea

Keywords

CPAP; diabetes; sleep apnea

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2

  The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline.

  Baseline and Week 2

Secondary Outcomes (3)

• Change From Baseline in Insulin Sensitivity (SI) at Week 2

  Baseline and Week 2

• Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2

  Baseline and Week 2

• Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2

  Baseline and Week 2

Study Arms (2)

Continuous positive airway pressure

ACTIVE COMPARATOR

2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night

Device: CPAP mask

Placebo

PLACEBO COMPARATOR

2 weeks of oral administration of a placebo tablet 30min before bedtime

Drug: Placebo

Interventions

CPAP mask DEVICE

The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Also known as: continuous positive airway pressure therapy

Continuous positive airway pressure

Placebo DRUG

oral placebo tablet

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight or obese adults (age ≥45 yrs and BMI ≥25 kg/m2)
• prediabetes and OSA (AHI ≥ 5)
• regular life styles and schedules (no shift work in the past 6 months, no travel across time zones during the past 4 weeks)
• habitual bedtimes of at least 6 hours but not exceeding 9 hours will be eligible.
• not to take any medications during the study period with the exception of antihypertensives and lipid lowering agents
• not on hormone replacement therapy.
• have sedentary activities and no competitive athletes or subjects with high exercise levels.

You may not qualify if:

• previous or current treatment with supplemental oxygen
• requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
• presence of active infection, psychiatric disease or history of other significant illness (e.g., myocardial infarction, congestive heart failure, stroke, arrhythmia, chronic kidney or liver disease0
• clinical depression as evidenced by a score \>16 in CES-D scale
• smoking, or routine alcohol use (more than 2 drinks per day), or excessive caffeine intake (\>300mg per day)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Pamidi S, Chapotot F, Wroblewski K, Whitmore H, Polonsky T, Tasali E. Optimal Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Reduces Daytime Resting Heart Rate in Prediabetes: A Randomized Controlled Study. J Am Heart Assoc. 2020 Oct 20;9(19):e016871. doi: 10.1161/JAHA.120.016871. Epub 2020 Oct 1.

  PMID: 32998624 DERIVED

• Pamidi S, Wroblewski K, Stepien M, Sharif-Sidi K, Kilkus J, Whitmore H, Tasali E. Eight Hours of Nightly Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Improves Glucose Metabolism in Patients with Prediabetes. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2015 Jul 1;192(1):96-105. doi: 10.1164/rccm.201408-1564OC.

  PMID: 25897569 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Esra Tasali
• Organization: University of Chicago

etasali@medicine.bsd.uchicago.edu

773-702-1497

Study Officials

• Esra Tasali, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: July 2, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 27, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-05

Locations

US (1)