N/A
Completed N=6
Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI
Spinal Cord Injuries · Obesity · Insulin Resistance
Source: ClinicalTrials.gov NCT02973438 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR) — 1.67; 1.60 IR Score
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR) |
1.67; 1.60 | — |
| SECONDARY Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test |
63.2; 64.9; 51.4; 70.9 | — |
Eligibility Criteria
Inclusion Criteria
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%
Exclusion Criteria (SCI and non injured control):
- 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.
Data sourced from ClinicalTrials.gov (NCT02973438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.