Diabetes MellitusNCT05404789
Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia
A study testing Centrifugation in people with Diabetes Mellitus and Arrhythmias, Cardiac, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The study will involve exposing individuals with a known past medical history of diabetes mellitus and/or cardiac arrhythmias to centrifuge-induced acceleration force (G-force) in the NASTAR AFTS-400 simulator to evaluate their response to such forces. 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, Arrhythmias, Cardiac
- What is being tested?
- Centrifugation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to 1 Oct 2022
- 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
- We aim to screen individuals known to have either of the following: (1) well-controlled diabetes mellitus (Type I or Type II, controlled with diet, oral medications, or insulin injections or pump) with an HbA1c of <8% or (2) well-controlled cardiac arrhythmias (including control via oral medications, implanted pacemakers, prior ablation or similar intervention). Cardiac arrhythmias of interest include Wolff-Parkinson-White (WPW), atrial fibrillation, atrial flutter, supraventricular tachycardia, accelerated idioventricular rhythms, junctional rhythms, A-V block. Use of an implanted permanent pacemaker (single- or dual-chamber, continuous or demand), if demonstrated to be successful in controlling prior arrhythmia, is acceptable. History of a one-time defibrillation event followed by successful ablation and/or management of an underlying disorder/arrhythmia is acceptable.
- Subjects with a history of both diabetes mellitus and cardiac arrhythmia are considered eligible for inclusion if both diseases meet inclusion criteria. The presence of other medical diseases (for example, history of prior myocardial infarction or stenting), if well-controlled, will still be considered eligible for inclusion (see exclusion criteria).
- We will further screen individuals with no known history of significant medical disease to act as a control group.
Who cannot join
- Disease-specific exclusion criteria include:
- Subjects with diabetes:
- An HbA1c ≥8%
- Demonstration of poor glucose control (with average preprandial baseline blood glucose of >250)
- Evidence of advanced disease or sequelae of long-term poor glucose management, such as significant or end-stage renal disease (creatinine of > 3.0 or reliance on hemodialysis), autonomic dysfunction, or diabetic retinopathy
- "Pre-diabetic" with normal HbA1c (<6.5%), no medications, no lifestyle changes
Show all 32Show fewer
- Subjects with cardiac arrhythmia:
- Evidence of symptomatic arrhythmias (for example, frequent light-headedness, syncopal events)
- Documentation of historical defibrillation events (note that a one-time defibrillation followed by intervention (example: ablation) and complete resolution of arrhythmic activity will NOT be considered exclusionary)
- Presence of an automated implanted cardiac defibrillator (AICD)
- History of ventricular tachycardia or ventricular fibrillation, if not otherwise related to an underlying and resolved condition
- Evidence of cardiac ischemia during any stress testing, severe vascular disease, or similar severe and uncontrolled medical problems identified by any historical documentation or pre-flight screening
- Female subjects will be required to be screened for pregnancy; pregnant patients will be excluded from this study. Subjects with extensive experience in the hypergravity environment, such as high performance or acrobatic pilots, will be ineligible.
- In addition, significant medical disease other than the diseases of interest may be exclusionary, particularly if they represent identifiable risk previously considered exclusionary from prior hypergravity exposure and centrifuge trials. Examples include:
- Poorly controlled hypertension (baseline systolic >180mmHg, baseline diastolic >100 mmHg)
- History of cardiac transplant
- History of cardiac ejection fraction of <50%
- Lung disease or cardiac disease requiring continuous supplemental oxygen therapy
- Acute spinal/neck/back injury
- Acute post-surgical period (<6wks)
- Severe obesity, with weight >250lbs
- History of unpredictable or uncontrollable psychiatric outbursts, disruptive behavior, etc
- Participants with significant cardiac risk factors beyond age and sex (including a history of tobacco use, a history of hyperlipidemia or dyslipidemia, a history of hypertension or blood pressure management with medication, or a history of diabetes) will be required to provide further information including lipid panels, HbA1c in the case of diabetes, and exercise stress testing. Patients will be excluded for:
- Evidence of cardiac ischemia during stress testing, with examples including:
- exercise-induced angina
- exercise-induced hypotension
- evidence of ≥1mm electrocardiogram ST-segment depression induced by exercise or pharmacological stress
- reversible ischemia on myocardial perfusion imaging
- Severe coronary vascular disease, with examples including:
- evidence of reversible ischemia on myocardial perfusion imaging,
- known history of multi-vessel coronary artery disease that has not received stenting or surgical correction (or is not amenable to stenting or surgical correction)
- Similar severe and uncontrolled medical problems identified by any of the screening medical monitors or physicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-1110
About this study
The study will involve exposing individuals with a known past medical history of diabetes mellitus and/or cardiac arrhythmias to centrifuge-induced acceleration force (G-force) in the NASTAR AFTS-400 simulator to evaluate their response to such forces. Subjects without a history of these conditions will also undergo centrifuge-induced G-forces as controls. This study will contribute to the knowledge of how individuals with such medical conditions experience G-forces that may be experienced during commercial spaceflights.
Read the detailed description
UTMB has received grant funding from the Federal Aviation Administration (FAA) under the Center of Excellence for Commercial Space Transportation to investigate these topics. The concern is whether spaceflight, an already hazardous endeavor, would be a greater hazard for the less healthy individual. It remains difficult to predict how particular disease processes will respond to the hypergravity environment during launch and landing of spacecraft, and exactly what these hazards may entail.
Conditions such as diabetes mellitus and cardiac arrhythmias may be prevalent in the population group of potential future spaceflight participants and may present additional risk factors in the hypergravity environment, from acceleration tolerance to the ability to carry out moderately complex tasks in emergency or high-stress operational scenarios. While certain disease-related sequelae (such as severe retinopathy, nephropathy, autonomic dysfunction, cardiac ischemia, etc) are likely to represent criteria for exclusion from near-future spaceflight activity, the inclusion of individuals with well-controlled disease without significant sequelae is desirable in the commercial spaceflight industry.
The purpose of this study is to evaluate the tolerance of acceleration forces, induced by centrifuge, in individuals with diabetes mellitus and cardiac arrhythmias. Investigators will include in the study individuals known to have either of the following:
- Well-controlled diabetes (type I or type II, controlled with diet, oral medications, or insulin injections, with HbA1c of <8% and baseline pre-prandial blood glucose of <250).
- Well-controlled cardiac arrhythmias (including control via oral medications, implanted pacemakers, or prior ablation or similar intervention). Cardiac arrhythmias of interest include Wolff-Parkinson-White (WPW), atrial fibrillation, atrial flutter, supraventricular tachycardia, accelerated idioventricular rhythms, junctional rhythms, A-V block. Use of an implanted pacemaker, if demonstrated to be successful in controlling prior dysrhythmia, is acceptable.
Investigators will further screen individuals with no known history of these diseases to act as a control group. It is anticipated that individuals with the controlled disease processes included in this study will tolerate acceleration forces well, with changes in cardiovascular responses related primarily to use of medications (primarily beta-blockers; see above for explanation). Investigators will also examine the performance, of both those with medical conditions and the controls, during a simulated emergency with a moderately difficult assigned task. It is hypothesized that these diseases, when well-controlled, are not a contraindication to space travel.
- Conditions
- Diabetes Mellitus, Arrhythmias, Cardiac
- Being tested
- Centrifugation
- Medical subject headings
- Diabetes Mellitus, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentrifugationOther
Subjects will participate in up to seven different centrifuge profiles over a single day of training (approximately 8 hours). Exposures are design to simulate a spaceflight profile using acceleration anticipated for commercial spaceflights.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Subjects | Other | Individuals with history of diabetes mellitus Receives: Other: Centrifugation |
| Subjects with history of arrhythmia | Other | Individuals with history of cardiac arrhythmia Receives: Other: Centrifugation |
| Control Subjects | Other | Individuals without history of either Diabetes or cardiac arrhythmia Receives: Other: Centrifugation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Abnormalities of heart rate (bpm) including bradycardia (<55bpm) or tachycardia outside of expected norms (>180) during acceleration phases
Measured: 5 seconds after the onset of acceleration
Systolic Blood Pressure - before
Measurement of systolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile
Measured: 5 minutes before centrifuge profile
Diastolic Blood Pressure - before
Measurement of diastolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile
Measured: 5 minutes before centrifuge profile
Systolic Blood Pressure - after
Measurement of systolic blood pressure (mmHg) at 5 minutes after centrifuge profile
Measured: 5 minutes before centrifuge profile
Diastolic Blood Pressure - after
Measurement of diastolic blood pressure (mmHg) at 5 minutes after centrifuge profile
Measured: 5 minutes after centrifuge profile
Blood Glucose
Blood glucose (g/dL) range on the day of testing
Measured: continuous blood glucose monitoring for 8 hours during day of testing
ECG dysrthythmias
Presence of dysrhythmias including PACs, PVCs, AIVR, or other rhythm alterations
Measured: up to 12 min, assessed during the duration of acceleration exposure
Errors during Emergency Scenario
During a simulated Emergency, subjects will enter 12 keystrokes on a touch-screen interface following completion of acceleration profiles. Outcome measures will include number of entry errors (e.g. wrong button, wrong order) during this examination
Measured: approximately 1 min, immediately following final acceleration profile
Time of data entry completion during Emergency Scenario
During a simulated Emergency, subjects will enter 12 keystrokes on a touch-screen interface following completion of acceleration profiles. Outcome measures will include the time to completion of all 12 keystrokes.
Measured: approximately 1 min, immediately following final acceleration profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start27 Sep 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparing layperson centrifuge tolerance between diabetics, individuals with past medical history of cardiac arrhythmia, and control subjects. All subjects will participate in the same protocols.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Civil Aerospace Medical Institute
- Responsible party
- Sponsor
- Investigators
- William Powers, MD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404789
- Sponsor's protocol ID
- 21-0078
- Status last verified
- Nov 2022
- First submitted
- 26 Aug 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia
- ClinicalTrials.gov ID
- NCT05404789
- Acronym / sponsor ID
- 21-0078
- Conditions
- Diabetes Mellitus, Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Civil Aerospace Medical Institute
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 3 Jun 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.
The study will involve exposing individuals with a known past medical history of diabetes mellitus and/or cardiac arrhythmias to centrifuge-induced acceleration force (G-force) in the NASTAR AFTS-400 simulator to evaluate their response to such forces. Subjects without a history of these conditions will also undergo centrifuge-induced G-forces as controls. This study will contribute to the knowledge of how individuals with such medical conditions experience G-forces that may be experienced during commercial spaceflights.
Detailed description
UTMB has received grant funding from the Federal Aviation Administration (FAA) under the Center of Excellence for Commercial Space Transportation to investigate these topics. The concern is whether spaceflight, an already hazardous endeavor, would be a greater hazard for the less healthy individual. It remains difficult to predict how particular disease processes will respond to the hypergravity environment during launch and landing of spacecraft, and exactly what these hazards may entail.
Conditions such as diabetes mellitus and cardiac arrhythmias may be prevalent in the population group of potential future spaceflight participants and may present additional risk factors in the hypergravity environment, from acceleration tolerance to the ability to carry out moderately complex tasks in emergency or high-stress operational scenarios. While certain disease-related sequelae (such as severe retinopathy, nephropathy, autonomic dysfunction, cardiac ischemia, etc) are likely to represent criteria for exclusion from near-future spaceflight activity, the inclusion of individuals with well-controlled disease without significant sequelae is desirable in the commercial spaceflight industry.
The purpose of this study is to evaluate the tolerance of acceleration forces, induced by centrifuge, in individuals with diabetes mellitus and cardiac arrhythmias. Investigators will include in the study individuals known to have either of the following:
- Well-controlled diabetes (type I or type II, controlled with diet, oral medications, or insulin injections, with HbA1c of <8% and baseline pre-prandial blood glucose of <250).
- Well-controlled cardiac arrhythmias (including control via oral medications, implanted pacemakers, or prior ablation or similar intervention). Cardiac arrhythmias of interest include Wolff-Parkinson-White (WPW), atrial fibrillation, atrial flutter, supraventricular tachycardia, accelerated idioventricular rhythms, junctional rhythms, A-V block. Use of an implanted pacemaker, if demonstrated to be successful in controlling prior dysrhythmia, is acceptable.
Investigators will further screen individuals with no known history of these diseases to act as a control group. It is anticipated that individuals with the controlled disease processes included in this study will tolerate acceleration forces well, with changes in cardiovascular responses related primarily to use of medications (primarily beta-blockers; see above for explanation). Investigators will also examine the performance, of both those with medical conditions and the controls, during a simulated emergency with a moderately difficult assigned task. It is hypothesized that these diseases, when well-controlled, are not a contraindication to space travel.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparing layperson centrifuge tolerance between diabetics, individuals with past medical history of cardiac arrhythmia, and control subjects. All subjects will participate in the same protocols.
| Arm | Type | Receives |
|---|---|---|
| Diabetic Subjects | Other | Other: CentrifugationIndividuals with history of diabetes mellitus |
| Subjects with history of arrhythmia | Other | Other: CentrifugationIndividuals with history of cardiac arrhythmia |
| Control Subjects | Other | Other: CentrifugationIndividuals without history of either Diabetes or cardiac arrhythmia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- We aim to screen individuals known to have either of the following: (1) well-controlled diabetes mellitus (Type I or Type II, controlled with diet, oral medications, or insulin injections or pump) with an HbA1c of <8% or (2) well-controlled cardiac arrhythmias (including control via oral medications, implanted pacemakers, prior ablation or similar intervention). Cardiac arrhythmias of interest include Wolff-Parkinson-White (WPW), atrial fibrillation, atrial flutter, supraventricular tachycardia, accelerated idioventricular rhythms, junctional rhythms, A-V block. Use of an implanted permanent pacemaker (single- or dual-chamber, continuous or demand), if demonstrated to be successful in controlling prior arrhythmia, is acceptable. History of a one-time defibrillation event followed by successful ablation and/or management of an underlying disorder/arrhythmia is acceptable.
- Subjects with a history of both diabetes mellitus and cardiac arrhythmia are considered eligible for inclusion if both diseases meet inclusion criteria. The presence of other medical diseases (for example, history of prior myocardial infarction or stenting), if well-controlled, will still be considered eligible for inclusion (see exclusion criteria).
- We will further screen individuals with no known history of significant medical disease to act as a control group.
Key exclusion criteria (32 listed)
- Disease-specific exclusion criteria include:
- Subjects with diabetes:
- Subjects with cardiac arrhythmia:
- Female subjects will be required to be screened for pregnancy; pregnant patients will be excluded from this study. Subjects with extensive experience in the hypergravity environment, such as high performance or acrobatic pilots, will be ineligible.
- In addition, significant medical disease other than the diseases of interest may be exclusionary, particularly if they represent identifiable risk previously considered exclusionary from prior hypergravity exposure and centrifuge trials. Examples include:
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 |
|---|---|---|
| CentrifugationSubjects will participate in up to seven different centrifuge profiles over a single day of training (approximately 8 hours). Exposures are design to simulate a spaceflight profile using acceleration anticipated for commercial spaceflights. | Other | Control Subjects, Diabetic Subjects, Subjects with history of arrhythmia |
Primary outcome
Heart Rate
Time frame: 5 seconds after the onset of acceleration
Abnormalities of heart rate (bpm) including bradycardia (<55bpm) or tachycardia outside of expected norms (>180) during acceleration phases
Systolic Blood Pressure - before
Time frame: 5 minutes before centrifuge profile
Measurement of systolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile
Diastolic Blood Pressure - before
Time frame: 5 minutes before centrifuge profile
Measurement of diastolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile
Systolic Blood Pressure - after
Time frame: 5 minutes before centrifuge profile
Measurement of systolic blood pressure (mmHg) at 5 minutes after centrifuge profile
Diastolic Blood Pressure - after
Time frame: 5 minutes after centrifuge profile
Measurement of diastolic blood pressure (mmHg) at 5 minutes after centrifuge profile
Blood Glucose
Time frame: continuous blood glucose monitoring for 8 hours during day of testing
Blood glucose (g/dL) range on the day of testing
ECG dysrthythmias
Time frame: up to 12 min, assessed during the duration of acceleration exposure
Presence of dysrhythmias including PACs, PVCs, AIVR, or other rhythm alterations
Errors during Emergency Scenario
Time frame: approximately 1 min, immediately following final acceleration profile
During a simulated Emergency, subjects will enter 12 keystrokes on a touch-screen interface following completion of acceleration profiles. Outcome measures will include number of entry errors (e.g. wrong button, wrong order) during this examination
Time of data entry completion during Emergency Scenario
Time frame: approximately 1 min, immediately following final acceleration profile
During a simulated Emergency, subjects will enter 12 keystrokes on a touch-screen interface following completion of acceleration profiles. Outcome measures will include the time to completion of all 12 keystrokes.
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 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.
William Powers, MD principal investigator
The University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centrifugation in people with Diabetes Mellitus and Arrhythmias, Cardiac, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 3 inclusion and 32 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 4 Nov 2022. 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 United States. 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?
Heart Rate (time frame: 5 seconds after the onset of acceleration). The study lists 9 primary outcomes in all. 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 4 Nov 2022.