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

NCT05404789 | Completed

• 1 other identifier: 21-0078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (9)

• Heart Rate

  Abnormalities of heart rate (bpm) including bradycardia (\<55bpm) or tachycardia outside of expected norms (\>180) during acceleration phases

  5 seconds after the onset of acceleration

• Systolic Blood Pressure - before

  Measurement of systolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile

  5 minutes before centrifuge profile

• Diastolic Blood Pressure - before

  Measurement of diastolic blood pressure (mmHg) at 5 minutes prior to centrifuge profile

  5 minutes before centrifuge profile

• Systolic Blood Pressure - after

  Measurement of systolic blood pressure (mmHg) at 5 minutes after centrifuge profile

  5 minutes before centrifuge profile

• Diastolic Blood Pressure - after

  Measurement of diastolic blood pressure (mmHg) at 5 minutes after centrifuge profile

  5 minutes after centrifuge profile

• Blood Glucose

  Blood glucose (g/dL) range on the day of testing

  continuous blood glucose monitoring for 8 hours during day of testing

• ECG dysrthythmias

  Presence of dysrhythmias including PACs, PVCs, AIVR, or other rhythm alterations

  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

  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.

  approximately 1 min, immediately following final acceleration profile

Study Arms (3)

Diabetic Subjects

OTHER

Individuals with history of diabetes mellitus

Other: Centrifugation

Subjects with history of arrhythmia

OTHER

Individuals with history of cardiac arrhythmia

Other: Centrifugation

Control Subjects

OTHER

Individuals without history of either Diabetes or cardiac arrhythmia

Other: Centrifugation

Interventions

Centrifugation OTHER

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.

Control Subjects; Diabetic Subjects; Subjects with history of arrhythmia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• We will further screen individuals with no known history of significant medical disease to act as a control group.
• 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
• Subjects with cardiac arrhythmia:
• Evidence of symptomatic arrhythmias (for example, frequent light-headedness, syncopal events)
• 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.
• Poorly controlled hypertension (baseline systolic \>180mmHg, baseline diastolic \>100 mmHg)
• History of cardiac transplant
• History of cardiac ejection fraction of \<50%

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Civil Aerospace Medical Institute: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-1110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Arrhythmias, Cardiac

Interventions

Centrifugation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• William Powers, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: June 3, 2022
• Study Start: September 27, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)