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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02973438
Other study ID # 20160818
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date December 2018

Study information

Verified date November 2020
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Device:
Intermittent Hypoxia (IH)
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%.
SHAM
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).

Locations

Country Name City State
United States The Miami Project to Cure Paralysis Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test Change in exercise substrate partitioning as measured via endurance-maximal oxygen consumption (VO2peak test) and will be reported as change in carbohydrate oxidation (% of total energy expenditure). Baseline, day 5
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