Carotid body dysfunction in type 2 diabetes
- Conditions
- Diabetes Mellitus10012653
- Registration Number
- NL-OMON50001
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
18 years and older
Non insulin dependent DM
No medical disease
Vital signs within specific boundries
Healthy apart from their DM
\See page 13 of the protocol
* Insulin dependent diabetes mellitus
* Diagnosed Obstructive Sleep Apnea (OSAS) or high suspicion of OSAS determined
by a STOP-BANG score > 5
* Respiratory or cardiovascular disease
* Smoking/vaping
* Positive pregnancy test
* conditions that result in elevated levels of methaemoglobinia
* body mass index > 35 kg/m2
* Use of illicit drugs
* Use of prescription opioids or benzodiazepines
* Failure of the drug of abuse tests at screening or check-in.
* History of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary
disease, or any other ventilatory / lung disease.
* Subjects with excessive facial hair preventing sealing of the occlusive face
mask.
* Subjects who, in the opinion of the investigator, will not be able to
participate optimally in the study.
* Subject who has a history of any infectious disease within 4 weeks prior to
drug administration that in the opinion of the investigator, affects the
subject*s ability to participate in the trial.
* Subjects who are part of the study staff personnel or family members of the
study staff personnel.
* Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic
reactions or asthmatic episodes) which, in the opinion of the investigator and
sponsor, interfere with their ability to participate in the trial.
* Personal or family history of arrhythmias or ECG conductance abnormalities.
* Hypokalemia defined as <3.5 mmol/L
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method