Diabetes Mellitus, Type 2CBHypoxiaNCT05237076
Carotid Body Function in Type 2 Diabetes Mellitus
A study testing Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR) in people with Diabetes Mellitus, Type 2 and Hypoxia, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This trial will assess chemosensitivity differences of the carotid bodies in individuals with T2DM, compared to healthy controls. During baseline and hyperinsulinemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypoxia
- What is being tested?
- Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2021to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 18 years and older
- Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedule.
- Non-insulin-dependent diabetes mellitus (NIDDM) or healthy sex, age (± 3 yrs) and BMI (± 3 kg/m2) matched controls.
- Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead ECG conduction intervals must be within gender specific normal range (e.g., QTcF ≤ 430 msec, PR interval ≤ 220 msec). ECGs are to be judged by the investigator or sub investigator as per standardized procedures.
- Vital sign measurements must be within the following ranges: (Individuals with values outside (or indicate lower or higher) of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.
Show all 33Show fewer
- body temperature, between 35.5°C and 37.5°C
- systolic blood pressure, 90 to 150 mmHg
- diastolic blood pressure, 40 to 95 mmHg
- pulse rate, 40 to 100 bpm
- Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
- Subjects presenting out of range values of lab/ECG/vital signs compatible with normal variation of the normal healthy subject can be included in the study at the investigator's discretion and sponsor written approval.
- Positive Allen's test
- Fitzpatrick skin type I or II
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carotid Body Dysfunction in Type 2 Diabetes
This trial will assess chemosensitivity differences of the carotid bodies in individuals with T2DM, compared to healthy controls. During baseline and hyperinsulinemia.
Read the detailed description
During the COVID-19 pandemic patients with comorbidities such as hypertension, diabetes mellitus, obesity and pregnancy were overrepresented in the population that was admitted to the hospital. Morbidity and mortality due to SARS-COV-2 infection was higher in these patients compared to patients without these comorbidities. The higher incidence, morbidity and mortality is suggestive of an underlying mechanism that puts these patients more at risk. A proposed mechanism is the sympathetic overactivity that is associated with these conditions. Recently, it has become clear that the carotid bodies play an important role in sympathetic overactivity in these conditions. Dysfunction of this organ is associated with decreased chemosensitivity, disruption of insulin sensitivity, but is also associated with changes in neurohumoral control in response to infection. Whether carotid body dysfunction can explain the severity of SARS-COV-2 infection remains to be seen. The aim of this study is to find whether patients with type 2 diabetes have altered chemosensitivity and are in fact sympathetically overactive compared to healthy controls and during a hyperinsulinemic-euglycemic clamp. Findings could help explain why type 2 diabetes patients are more heavily affected by SARS-COV-2 and could identify potential targets for treatment in these patients.
- Conditions
- Diabetes Mellitus, Type 2, Hypoxia
- Being tested
- Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)Diagnostic test
Hyperinsulemic-Euglycemic Clamp as described by deFronzo et al.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Type 2 | Experimental | Patients with DM Type 2 using Oral Diabetes Medications only. Receives: Diagnostic Test: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR) |
| Healthy controls | Active comparator | Healthy controls without comorbidities. Receives: Diagnostic Test: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemosensitivity of carotid bodies during baseline and euglycemic clamp
L/min/PaO2
Measured: 5 minutes
Secondary outcomes (1)
HRV during baseline and euglycemic clamp
HRV parameters
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Dec 2021
- Primary completion5 Aug 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Multi arm pre-post study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Demcon
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
- Investigators
- Albert Dahan, MD, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237076
- Sponsor's protocol ID
- NL78476.058.21
- Acronym
- CBHypoxia
- Status last verified
- May 2023
- First submitted
- 2 Feb 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Body Dysfunction in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05237076
- Acronym / sponsor ID
- CBHypoxia / NL78476.058.21
- Conditions
- Diabetes Mellitus, Type 2, Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Demcon
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess chemosensitivity differences of the carotid bodies in individuals with T2DM, compared to healthy controls. During baseline and hyperinsulinemia.
Detailed description
During the COVID-19 pandemic patients with comorbidities such as hypertension, diabetes mellitus, obesity and pregnancy were overrepresented in the population that was admitted to the hospital. Morbidity and mortality due to SARS-COV-2 infection was higher in these patients compared to patients without these comorbidities. The higher incidence, morbidity and mortality is suggestive of an underlying mechanism that puts these patients more at risk. A proposed mechanism is the sympathetic overactivity that is associated with these conditions. Recently, it has become clear that the carotid bodies play an important role in sympathetic overactivity in these conditions. Dysfunction of this organ is associated with decreased chemosensitivity, disruption of insulin sensitivity, but is also associated with changes in neurohumoral control in response to infection. Whether carotid body dysfunction can explain the severity of SARS-COV-2 infection remains to be seen. The aim of this study is to find whether patients with type 2 diabetes have altered chemosensitivity and are in fact sympathetically overactive compared to healthy controls and during a hyperinsulinemic-euglycemic clamp. Findings could help explain why type 2 diabetes patients are more heavily affected by SARS-COV-2 and could identify potential targets for treatment in these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi arm pre-post study
| Arm | Type | Receives |
|---|---|---|
| Diabetes Type 2 | Experimental | Diagnostic Test: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)Patients with DM Type 2 using Oral Diabetes Medications only. |
| Healthy controls | Active comparator | Diagnostic Test: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)Healthy controls without comorbidities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 18 years and older
- Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedule.
- Non-insulin-dependent diabetes mellitus (NIDDM) or healthy sex, age (± 3 yrs) and BMI (± 3 kg/m2) matched controls.
- Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead ECG conduction intervals must be within gender specific normal range (e.g., QTcF ≤ 430 msec, PR interval ≤ 220 msec). ECGs are to be judged by the investigator or sub investigator as per standardized procedures.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)Hyperinsulemic-Euglycemic Clamp as described by deFronzo et al. | Diagnostic test | Diabetes Type 2, Healthy controls |
Primary outcome
Chemosensitivity of carotid bodies during baseline and euglycemic clamp
Time frame: 5 minutes
L/min/PaO2
1 secondary outcome
HRV during baseline and euglycemic clamp
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided. On request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Dahan, MD, PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR) in people with Diabetes Mellitus, Type 2 and Hypoxia, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemosensitivity of carotid bodies during baseline and euglycemic clamp (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.