The aim of this research is twofold:1) Determining the functionality of the oxygen sensor in the neck (the glomus body or *carotid body* during the administration of glucose and insulin, a so-called euglycemic hyperinsular clamp.2) Validating a new…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hypoxic ventilatory response
Secondary outcome
Heart rate variability
Background summary
The glomus body (or carotid body, CB) is the main oxygen sensor in the blood.
In the event that the oxygen concentration in the blood decreases, this leads
to a hyperventilation reaction, which restores oxygen uptake. A drop in oxygen
concentration can occur during sleep, at high altitude, while flying in modern
airplanes, and also in the case of lung and heart disease. The functionality of
the CB is also important in diabetes mellitus because the CB also measures the
glucose concentration in the blood. Elevated levels of insulin in the blood in
particular can have an effect on the CBs. We want to study whether this also
influences breathing.
Study objective
The aim of this research is twofold:
1) Determining the functionality of the oxygen sensor in the neck (the glomus
body or *carotid body* during the administration of glucose and insulin, a
so-called euglycemic hyperinsular clamp.
2) Validating a new oxygen sensor on the skin. This sensor is glued to the
skin. This part of the research is being carried out in part by Demcom, a Dutch
engineering company.
Study design
Observational non randomized study
Study burden and risks
We estimate the burden as minor with the main side effect being headache (can
be treated well with paracetamol).
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
* 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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL78476.000.21 |