Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Apnea-hypopnea Syndrome (DM2-CPAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Sleep Apnea
• Intervention / Treatment: Device: Continuous Positive Airway Pressure CPAP

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelnoa
    • Granollers, Barcelnoa, Spain, 08402
      • Granollers General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Positive Airway Pressure; Continuous Positive Airway Pressure (CPAP)	Device: Continuous Positive Airway Pressure CPAP; CPAP treatment; Other Names: no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hemoglobine A1C from baseline	14, 28, 42 and 56 weeks after initial intervention.

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood levels of fasting glucose from baseline	14 weeks after initial intervention
Self measured capillary glucose profile	14 weeks after initial intervention
Evening saliva collection for cortisol assay	14 weeks after initial intervention
Noninvasive 24-hour ambulatory blood pressure monitoring	14 weeks after initial intervention.
Analysis of urine to assess albumin to creatinine ratio	0, 14, 28, and 56 weeks after initial intervention.
Blood levels of fasting insulin	14 weeks after initial intervention
Blood levels of total cholesterol	14 weeks after initial intervention
Blood levels of cholesterol HDL	14 weeks after initial intervention
Blood levels of tryglicerids	14 weeks after initial intervention
International Physical Activity Questionnaire	14 weeks after initial intervention
Epworth Sleepiness Scale	14 weeks after initial intervention
SF-36 v2 Health Survey	14 weeks after initial intervention
subjective quantity and quality of sleep reported in a sleep log	14 weeks after initial intervention
Change in ratio albumine to creatinine from baseline	14, 28, 42 and 56 weeks after initial intervention

Collaborators and Investigators

• Sponsor: Hospital de Granollers
• Collaborators: EsteveTeijin Healthcare
• Investigators: Principal Investigator: Marta Torrella, M.D., Granollers General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimate): March 3, 2011

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: DM2-CPAP