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

• ClinicalTrials.gov Identifier: NCT01307566
• Recruitment Status: Completed
• First Posted: March 3, 2011
• Last Update Posted: January 6, 2015
• Sponsor: Hospital de Granollers
• Collaborator: EsteveTeijin Healthcare
• Information provided by (Responsible Party): marta torrella, Hospital de Granollers

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea; Type 2 Diabetes	Device: Continuous Positive Airway Pressure CPAP	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Moderate to Severe Apnea-hypopnea Syndrome and Poor Glycemic Control
• Study Start Date: March 2011
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Continuous Positive Airway Pressure; Continuous Positive Airway Pressure (CPAP)	Device: Continuous Positive Airway Pressure CPAP; CPAP treatment; Other Name: no other name

Outcome Measures

Primary Outcome Measures :

1. Change in Hemoglobine A1C from baseline [ Time Frame: 14, 28, 42 and 56 weeks after initial intervention. ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Spain

Granollers General Hospital

Granollers, Barcelnoa, Spain, 08402

Sponsors and Collaborators

Hospital de Granollers

EsteveTeijin Healthcare

Investigators

• Principal Investigator: Marta Torrella, M.D.; Granollers General Hospital

More Information

• Responsible Party: marta torrella, Chest Physician in Unitat de Pneumologia, Hospital de Granollers
• ClinicalTrials.gov Identifier: NCT01307566
• Other Study ID Numbers: DM2-CPAP
• First Posted: March 3, 2011
• Last Update Posted: January 6, 2015
• Last Verified: January 2015

Additional relevant MeSH terms:

Apnea; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms