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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01307566
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : January 6, 2015
Sponsor:
Collaborator:
EsteveTeijin Healthcare
Information provided by (Responsible Party):
marta torrella, Hospital de Granollers

Tracking Information
First Submitted Date  ICMJE February 11, 2011
First Posted Date  ICMJE March 3, 2011
Last Update Posted Date January 6, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
Change in Hemoglobine A1C from baseline [ Time Frame: 14, 28, 42 and 56 weeks after initial intervention. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Apnea-hypopnea Syndrome
Official Title  ICMJE Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Moderate to Severe Apnea-hypopnea Syndrome and Poor Glycemic Control
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea
  • Type 2 Diabetes
Intervention  ICMJE Device: Continuous Positive Airway Pressure CPAP
CPAP treatment
Other Name: no other name
Study Arms  ICMJE Experimental: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure (CPAP)
Intervention: Device: Continuous Positive Airway Pressure CPAP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2011)
70
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01307566
Other Study ID Numbers  ICMJE DM2-CPAP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party marta torrella, Hospital de Granollers
Study Sponsor  ICMJE Hospital de Granollers
Collaborators  ICMJE EsteveTeijin Healthcare
Investigators  ICMJE
Principal Investigator: Marta Torrella, M.D. Granollers General Hospital
PRS Account Hospital de Granollers
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP