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Carotid body dysfunction in type 2 diabetes

Carotid body dysfunction in type 2 diabetes - Carotid body function in T2DM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50001
Enrollment
30
Registered
2021-10-08
Start date
2021-12-03
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Hypoxic ventilatory response

Secondary

MeasureTime frame
Heart rate variability

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)