The main purpose of this study is to measure the evolution of hemoglobin A1c level after treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic control and associated moderate or severe obstructive sleep apnea.
Subjects with poorly controlled type 2 diabetes are a high cardiovascular risk group in which a high prevalence of moderate to severe sleep apnea is expected. Studies based on interstitial glycemic measurement demonstrate a reduction in glucose levels when treating sleep apnea with CPAP. Nevertheless, the effectiveness of CPAP in improving glycemic control has been questioned as most studies have failed to demonstrate a reduction in hemoglobin A1c (HbA1C) level over time. Most of these studies have limitations such as a short follow-up or a suboptimal fulfillment of CPAP treatment. We hypothesize that treating moderate to severe sleep apnea with CPAP will improve glycemic control (measured by HbA1C) at 14 weeks in good compliers and that this improvement will be sustained at one year. We aim to test this hypothesis in consecutive type 2 diabetes patients on stable treatment with HbA1c ≥7% in routine outpatient visits in our Diabetes, Nutrition and Endocrinology Unit. After providing informed consent, patients will be screened for sleep apnea by nocturnal oximetry followed by a diagnostic respiratory polygraphy. Those patients with obstructive sleep apnea with an apnea-hypopnea index ≥20 will be invited to enter the study. After a 3-month observation period without any intervention to rule out a potential influence of entering the study on HbA1C levels, patients will be treated with CPAP. HbA1C levels will be measured at baseline, after 14 weeks, and thereafter every 14 weeks until completing one year of treatment. Other endocrine, metabolic and cardiovascular risk variables will be determined at baseline and at 14 weeks of the intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
CPAP treatment
Granollers General Hospital
Granollers, Barcelnoa, Spain
Change in Hemoglobine A1C from baseline
Time frame: 14, 28, 42 and 56 weeks after initial intervention.
Blood levels of fasting glucose from baseline
Time frame: 14 weeks after initial intervention
Self measured capillary glucose profile
Time frame: 14 weeks after initial intervention
Evening saliva collection for cortisol assay
Time frame: 14 weeks after initial intervention
Noninvasive 24-hour ambulatory blood pressure monitoring
Time frame: 14 weeks after initial intervention.
Analysis of urine to assess albumin to creatinine ratio
Time frame: 0, 14, 28, and 56 weeks after initial intervention.
Blood levels of fasting insulin
Time frame: 14 weeks after initial intervention
Blood levels of total cholesterol
Time frame: 14 weeks after initial intervention
Blood levels of cholesterol HDL
Time frame: 14 weeks after initial intervention
Blood levels of tryglicerids
Time frame: 14 weeks after initial intervention
International Physical Activity Questionnaire
Time frame: 14 weeks after initial intervention
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Epworth Sleepiness Scale
Time frame: 14 weeks after initial intervention
SF-36 v2 Health Survey
Time frame: 14 weeks after initial intervention
subjective quantity and quality of sleep reported in a sleep log
Time frame: 14 weeks after initial intervention
Change in ratio albumine to creatinine from baseline
Time frame: 14, 28, 42 and 56 weeks after initial intervention