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Completed

NCT Number: NCT01307566

Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Apnea-hypopnea Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes on stable treatment for the last three months and HbA1C ≥ 7%
  • Obstructive Sleep Apnea with and apnea-hypopnea index ≥20
  • Acceptance of a therapeutic trial with CPAP

Exclusion criteria

  • Race: non caucasic
  • Blood level of hemoglobin <10 in women or <11 in men or iron defitiency or hemoglobinopathy
  • Glomerular filtration rate < 30
  • Habitual sleeping time <6 hours per night
  • Nocturnal work, shift work or unsual sleeping schedule
  • Primary severe insomnia or secondary to restless legs syndrome
  • Major or non stable psychiatric disorder
  • Treatment with corticosteroids
  • Chronic respiratory disorders that may require corticosteroids or cause respiratory insufficiency or FEV1/FVC<0.7 with FEV1<50 in spirometry
  • Predominant nocturnal hypoventilation pattern
  • Cardiac failure
  • Alcohol abuse
  • Active CPAP treatment
  • Previous surgery for sleep apnea
  • Severe nasal obstruction
  • Illiteracy

Treatment and study plan

Continuous Positive Airway Pressure CPAP

Device

CPAP treatment

Other names: no other name

Primary outcomes

  1. Change in Hemoglobine A1C from baseline

    Time frame: 14, 28, 42 and 56 weeks after initial intervention.

Secondary outcomes

  1. Blood levels of fasting glucose from baseline

    Time frame: 14 weeks after initial intervention

  2. Self measured capillary glucose profile

    Time frame: 14 weeks after initial intervention

  3. Evening saliva collection for cortisol assay

    Time frame: 14 weeks after initial intervention

  4. Noninvasive 24-hour ambulatory blood pressure monitoring

    Time frame: 14 weeks after initial intervention.

  5. Analysis of urine to assess albumin to creatinine ratio

    Time frame: 0, 14, 28, and 56 weeks after initial intervention.

  6. Blood levels of fasting insulin

    Time frame: 14 weeks after initial intervention

  7. Blood levels of total cholesterol

    Time frame: 14 weeks after initial intervention

  8. Blood levels of cholesterol HDL

    Time frame: 14 weeks after initial intervention

  9. Blood levels of tryglicerids

    Time frame: 14 weeks after initial intervention

  10. International Physical Activity Questionnaire

    Time frame: 14 weeks after initial intervention

  11. Epworth Sleepiness Scale

    Time frame: 14 weeks after initial intervention

  12. SF-36 v2 Health Survey

    Time frame: 14 weeks after initial intervention

  13. subjective quantity and quality of sleep reported in a sleep log

    Time frame: 14 weeks after initial intervention

  14. Change in ratio albumine to creatinine from baseline

    Time frame: 14, 28, 42 and 56 weeks after initial intervention

Sponsors and collaborators

Lead sponsor

Hospital de Granollers

Other

Collaborators

  • EsteveTeijin Healthcare

Registry information

Official study title

Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Moderate to Severe Apnea-hypopnea Syndrome and Poor Glycemic Control

Acronym: DM2-CPAP

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Mar 3, 2011
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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