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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hospital de Granollers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Granollers
ClinicalTrials.gov Identifier:
NCT01307566
First received: February 11, 2011
Last updated: March 4, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Sleep Apnea
Diabetes Mellitus, Non-Insulin-Dependent
 Device: Continuous Positive Airway Pressure CPAP

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Granollers:

Primary Outcome Measures:
  • Change in Hemoglobine A1C from baseline [ Time Frame: 14, 28, 42 and 56 weeks after initial intervention. ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 70
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure (CPAP)
 Device: Continuous Positive Airway Pressure CPAP
CPAP treatment
Other Name: no other name

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307566

Locations
Spain
Granollers General Hospital Recruiting
Granollers, Barcelnoa, Spain, 08402
Contact: Marta Torrella, M.D.     938425000     mtorrella@fhag.es    
Contact: diana navarro, Ph. D.     938425000     diananavarro@fhag.es    
Principal Investigator: Marta Torrella, M.D.            
Sponsors and Collaborators
Hospital de Granollers
Investigators
Principal Investigator: Marta Torrella, M.D. Granollers General Hospital
  More Information

No publications provided

Responsible Party: Marta Torrella Marcet, Unitat de Pneumologia, Hospital General de Granollers
ClinicalTrials.gov Identifier: NCT01307566     History of Changes
Other Study ID Numbers: DM2-CPAP
Study First Received: February 11, 2011
Last Updated: March 4, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Apnea
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013