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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03221205 |
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Date of registration:
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14/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients
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Scientific title:
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Effect of Nasal CPAP on Myocardial Dysfunction and Glycemic Control in Patients With Type 2 Diabetes, Obstructive Sleep Apnea and Obesity |
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Date of first enrolment:
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October 15, 2014 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03221205 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Armando R Castorena-Maldonado, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Enfermedades Respiratorias |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical data of obstructive sleep apnea: snoring, witnessed apneas, excessive daytime
somnolence.
- Previous diagnosis of type 2 diabetes mellitus, with medical treatment according to
the ADA 2012 guidelines, but only with one of the next drugs: biguanides,
sulphonylurea, meglitinide, thiazolidinedione, alpha-glucosidase inhibitors.
- Obesity, defined by a body mass index higher than 29 kilogram per square meter.
Exclusion Criteria:
- Type 1 diabetes mellitus.
- Insulin dependent type 2 diabetes mellitus
- Fasting plasma glucose higher than 212 mg/dL .
- Antecedent of myocardial infarction, heart failure or arrhythmia.
- Obstructive sleep apnea in treatment.
- Urgent need of CPAP treatment (public transport drivers, heavy machine operators).
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sleep Apnea, Obstructive
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Obesity
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Diabetes Mellitus, Type 2
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Myocardial Dysfunction
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Echocardiography
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Continuous Positive Airway Pressure
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Intervention(s)
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Device: Sham CPAP
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Device: Therapeutic CPAP
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Primary Outcome(s)
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Strain
[Time Frame: After 3 months of CPAP use.]
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TEI index
[Time Frame: After 3 months of CPAP use.]
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Secondary Outcome(s)
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Plasma glucose.
[Time Frame: After 3 months of CPAP use.]
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Time of hypercapnia
[Time Frame: After 3 months of CPAP use.]
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Highest CO2
[Time Frame: After three months CPAP use]
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Hemoglobin A1C
[Time Frame: After three months of CPAP use.]
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Mean CO2
[Time Frame: After three months CPAP use]
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Mean value of arterial pressure
[Time Frame: After 3 months of CPAP use]
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Time of hypercapnia
[Time Frame: After three months CPAP use.]
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Mean oxygen saturation
[Time Frame: After 3 months of CPAP use.]
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Time of saturation under 90%.
[Time Frame: After 3 months CPAP use]
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Apnea hypopnea index
[Time Frame: After 3 months CPAP use.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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