Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Diabetes Clinical Trial

Official title:

Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156116
• Other study ID #: 09-249-A
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: May 22, 2015
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: May 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Diabetes
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP mask
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. ________________________________________

Drug:
• Placebo
oral placebo tablet

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Insulin Sensitivity (SI) at Week 2	SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).; Change = Week 2 - Baseline.	Baseline and Week 2	No
Secondary	Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2	The average systolic blood pressure measured over a 24-hr period was calculated for each patient.; Change = Week 2 - Baseline.	Baseline and Week 2	No
Secondary	Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2	The average diastolic blood pressure over a 24-hr period was calculated for each patient.; Change = Week 2 - Baseline	Baseline and Week 2	No