Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03221205
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT03221205
Study Brief:
Protocol Section:
NCT03221205