Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI
Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this research is to examine changes in blood glucose control and metabolism in individuals with SCI and non injured controls at rest and during exercise after five days of exposure to IH. This response will be compared with breathing normal room air (a SHAM control).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
December 17, 2020
CompletedDecember 17, 2020
November 1, 2020
2 years
November 18, 2016
February 26, 2020
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of \> 1.8 were considered insulin resistant.
Baseline, day 5
Secondary Outcomes (1)
Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test
Baseline, day 5
Study Arms (4)
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM
EXPERIMENTALThis arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Control (CON) Intermittent Hypoxia then SHAM
EXPERIMENTALThis arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
EXPERIMENTALThis arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Control (CON) SHAM then Intermittent Hypoxia
EXPERIMENTALThis arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Interventions
Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.
Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
Eligibility Criteria
You may qualify if:
- SCI only:
- Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
- ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI) (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).
- SCI and non injured control:
- Resting SaO2 ≥ 95%
You may not qualify if:
- Currently hospitalized
- Resting heart rate ≥120 BPM
- Resting systolic blood pressure \>180 mm Hg
- Resting diastolic Blood Pressure \>100 mmHg
- Self-reported history of unstable angina or myocardial infarction within the previous month
- Previous cardiac surgery or condition that evidences ischemic heart disease
- Cardiopulmonary complication such as COPD
- Pregnancy determined by urine testing in sexually active females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Miami Project to Cure Paralysis
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark S. Nash, Ph.D.
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S Nash, PhD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 18, 2016
First Posted
November 25, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
December 17, 2020
Results First Posted
December 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share