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Completed

NCT Number: NCT01801150

CPAP in Diabetes Type 2 Patients With Sleep Apnea

Aim: To assess if six months of treatment with CPAP associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome SAHS)

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz- IdiPaz

Madrid, 28046, Spain

About this study

Main objective:

To assess the effect of 6 months of CPAP treatment associated with conventional drug therapy on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of HbA1c> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (BMI ≥ 25 kg/m2)

Exclusion criteria

  • professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale> 18); morbid obesity (BMI> 40 kg/m2); CPAP treatment

Treatment and study plan

CPAP nasal treatment

Device

Treatment with titred CPAP nasal during the nighttime

Primary outcomes

  1. Glycemic control

    Time frame: Six months

    To assess the effect of 6 months of CPAP therapy and conventional treatment on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)

Secondary outcomes

  1. To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.

    Time frame: 6 months

    . Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.

Other outcomes

  1. Impact of CPAP on glycemic control

    Time frame: 6 months

    Analyze the impact of additional treatment with CPAP on serum lipids and C-reactive protein concentration in patients with type 2 diabetes and SAHS

  2. Quality of life after CPAP

    Time frame: 6 months

    Establish the impact of additional treatment with CPAP on quality of life related to health of patients with type 2 diabetes and SAHS.

  3. Inflammatory markers after CPAP

    Time frame: 6 months

    To evaluate the effect of CPAP on inflammatory cytokines, biomarkers of oxidative stress, sympathetic tone and intake regulating hormones in patients with type 2 diabetes and SAHS.

  4. Endocrine control with CPAP treatment

    Time frame: 6 months

    Relate the CPAP-induced changes in the concentration of HbA1c and HOMA index with changes produced in the basal inflammatory reaction, oxidative stress, sympathetic activity and intake regulatory hormones.

    Identify the subset of patients with poorly controlled type 2 diabetes and SAHS in the six months of treatment with CPAP achieve a more pronounced reduction in HbA1c.

  5. Influence of body distribution and activity on metabolic control

    Time frame: 6 months

    To estimate the influence of the distribution of body mass and daily physical activity of patients with type 2 diabetes and SAHS on the metabolic response to treatment with CPAP.

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome

Acronym: DM-SAHS

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 28, 2013
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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