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Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia

Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05404789
Enrollment
50
Registered
2022-06-03
Start date
2021-09-27
Completion date
2022-10-01
Last updated
2022-11-04

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

Conditions

Diabetes Mellitus, Arrhythmias, Cardiac

Brief 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. 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: 1. 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). 2. 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.

Interventions

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.

Sponsors

Civil Aerospace Medical Institute
CollaboratorFED
The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Blood Glucosecontinuous blood glucose monitoring for 8 hours during day of testingBlood glucose (g/dL) range on the day of testing
ECG dysrthythmiasup to 12 min, assessed during the duration of acceleration exposurePresence of dysrhythmias including PACs, PVCs, AIVR, or other rhythm alterations
Heart Rate5 seconds after the onset of accelerationAbnormalities of heart rate (bpm) including bradycardia (\<55bpm) or tachycardia outside of expected norms (\>180) during acceleration phases
Systolic Blood Pressure - before5 minutes before centrifuge profileMeasurement of systolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile
Diastolic Blood Pressure - before5 minutes before centrifuge profileMeasurement of diastolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile
Systolic Blood Pressure - after5 minutes before centrifuge profileMeasurement of systolic blood pressure (mmHg) at 5 minutes after centrifuge profile
Diastolic Blood Pressure - after5 minutes after centrifuge profileMeasurement of diastolic blood pressure (mmHg) at 5 minutes after centrifuge profile
Errors during Emergency Scenarioapproximately 1 min, immediately following final acceleration profileDuring 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 Scenarioapproximately 1 min, immediately following final acceleration profileDuring 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026