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

Type 2 Diabetes Clinical Trial

— DM2-CPAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307566
• Other study ID #: DM2-CPAP
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: January 5, 2015
• Start date: March 2011
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Hospital de Granollers
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Type 2 Diabetes

Intervention

Device:
• Continuous Positive Airway Pressure CPAP
CPAP treatment

Locations

Country	Name	City	State
Spain	Granollers General Hospital	Granollers	Barcelnoa

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Granollers	EsteveTeijin Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobine A1C from baseline		14, 28, 42 and 56 weeks after initial intervention.	No
Secondary	Blood levels of fasting glucose from baseline		14 weeks after initial intervention	No
Secondary	Self measured capillary glucose profile		14 weeks after initial intervention	No
Secondary	Evening saliva collection for cortisol assay		14 weeks after initial intervention	No
Secondary	Noninvasive 24-hour ambulatory blood pressure monitoring		14 weeks after initial intervention.	No
Secondary	Analysis of urine to assess albumin to creatinine ratio		0, 14, 28, and 56 weeks after initial intervention.	No
Secondary	Blood levels of fasting insulin		14 weeks after initial intervention	No
Secondary	Blood levels of total cholesterol		14 weeks after initial intervention	No
Secondary	Blood levels of cholesterol HDL		14 weeks after initial intervention	No
Secondary	Blood levels of tryglicerids		14 weeks after initial intervention	No
Secondary	International Physical Activity Questionnaire		14 weeks after initial intervention	No
Secondary	Epworth Sleepiness Scale		14 weeks after initial intervention	No
Secondary	SF-36 v2 Health Survey		14 weeks after initial intervention	No
Secondary	subjective quantity and quality of sleep reported in a sleep log		14 weeks after initial intervention	No
Secondary	Change in ratio albumine to creatinine from baseline		14, 28, 42 and 56 weeks after initial intervention	No