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

NCT01307566 | Completed

• 1 other identifier: DM2-CPAP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobine A1C from baseline

  14, 28, 42 and 56 weeks after initial intervention.

Secondary Outcomes (14)

• 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.

Study Arms (1)

Continuous Positive Airway Pressure

EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Device: Continuous Positive Airway Pressure CPAP

Interventions

Continuous Positive Airway Pressure CPAP DEVICE

CPAP treatment

Also known as: no other name

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Granollers: lead
• EsteveTeijin Healthcare: collaborator

Study Sites (1)

Granollers General Hospital

Granollers, Barcelnoa, 08402, Spain

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Diabetes Mellitus, Type 2

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Marta Torrella, M.D.

  Granollers General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chest Physician in Unitat de Pneumologia

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: March 3, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

ES (1)