Insulin Resistance, Obesity, Spinal Cord Injuries
Conditions
Keywords
Spinal Cord Injuries, Obesity, Insulin Resistance, Intermittent hypoxia
Brief 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).
Interventions
DEVICEIntermittent 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%.
DEVICESHAM
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).
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR) | Baseline, day 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test | Baseline, day 5 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
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). | 2 |
| Control (CON) Intermittent Hypoxia Then SHAM This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
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). | 1 |
| Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
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). | 2 |
| Control (CON) SHAM Then Intermittent Hypoxia This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
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). | 1 |
| Total | 6 |
Baseline characteristics
| Characteristic | Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM | Control (CON) Intermittent Hypoxia Then SHAM | Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia | Control (CON) SHAM Then Intermittent Hypoxia | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 |
Outcome results
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.
Time frame: Baseline, day 5
Population: Unable to obtain blood samples from 2 participants in the control group and 1 participant withdrew prior to the baseline laboratory trial and therefore did not receive any intervention, therefore there is no reported data for the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury (SCI) Intermittent Hypoxia | Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR) | 1.67 IR Score | Standard Deviation 0.91 |
| Spinal Cord Injury (SCI) SHAM | Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR) | 1.60 IR Score | Standard Deviation 1.27 |
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).
Time frame: Baseline, day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury (SCI) Intermittent Hypoxia | Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test | 63.2 % of total energy expenditure. | Standard Deviation 25.7 |
| Control (CON) Intermittent Hypoxia | Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test | 64.9 % of total energy expenditure. | Standard Deviation 8.4 |
| Spinal Cord Injury (SCI) SHAM | Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test | 51.4 % of total energy expenditure. | Standard Deviation 23.6 |
| Control (CON) SHAM | Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test | 70.9 % of total energy expenditure. | Standard Deviation 3.8 |