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

University of Miami

Status: Completed

Conditions: Spinal Cord Injuries; Insulin Resistance; Obesity

Treatments: Device: SHAM; Device: Intermittent Hypoxia (IH)

Study type: Interventional

Funder types: Other

Identifiers

NCT02973438

20160818

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

SCI only:

1. Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
2. 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):

1. Currently hospitalized
2. Resting heart rate ≥120 BPM
3. Resting systolic blood pressure >180 mm Hg
4. Resting diastolic Blood Pressure >100 mmHg
5. Self-reported history of unstable angina or myocardial infarction within the previous month
6. Previous cardiac surgery or condition that evidences ischemic heart disease
7. Cardiopulmonary complication such as COPD
8. Pregnancy determined by urine testing in sexually active females.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 4 patient groups

Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM

Experimental group

Description:

This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.

Treatment:

Device: SHAM

Device: Intermittent Hypoxia (IH)

Control (CON) Intermittent Hypoxia then SHAM

Experimental group

Description:

This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.

Treatment:

Device: SHAM

Device: Intermittent Hypoxia (IH)

Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia

Experimental group

Description:

This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.

Treatment:

Device: SHAM

Device: Intermittent Hypoxia (IH)

Control (CON) SHAM then Intermittent Hypoxia

Experimental group

Description:

This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.

Treatment:

Device: SHAM

Device: Intermittent Hypoxia (IH)