Obesity Clinical Trial
Official title:
Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)
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 |
Verified date | November 2020 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Miami Project to Cure Paralysis | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
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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