N/A N=6 Randomized Single-blind Treatment

Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI

Spinal Cord Injuries · Obesity · Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT02973438 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR) — 1.67; 1.60 IR Score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intermittent Hypoxia (IH) (Device); SHAM (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Dec 2018

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	—

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).

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.

View full record on ClinicalTrials.gov →

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.