Trial Outcomes & Findings for Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI (NCT NCT02973438)
NCT ID: NCT02973438
Last Updated: 2020-12-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline, day 5
Results posted on
2020-12-17
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|
|
First Treatment Session (4 Days)
STARTED
|
2
|
1
|
2
|
1
|
|
First Treatment Session (4 Days)
COMPLETED
|
2
|
1
|
2
|
1
|
|
First Treatment Session (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (Three Weeks)
STARTED
|
2
|
1
|
2
|
1
|
|
Washout (Three Weeks)
COMPLETED
|
2
|
1
|
2
|
1
|
|
Washout (Three Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Treatment Session (4 Days)
STARTED
|
2
|
1
|
2
|
1
|
|
Second Treatment Session (4 Days)
COMPLETED
|
2
|
1
|
2
|
1
|
|
Second Treatment Session (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI
Baseline characteristics by cohort
| Measure |
Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM
n=2 Participants
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).
|
Control (CON) Intermittent Hypoxia Then SHAM
n=1 Participants
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).
|
Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia
n=2 Participants
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).
|
Control (CON) SHAM Then Intermittent Hypoxia
n=1 Participants
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).
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, day 5Population: 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.
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.
Outcome measures
| Measure |
Spinal Cord Injury (SCI) Intermittent Hypoxia
n=2 Participants
This arm of individuals with SCI will receive Intermittent Hypoxia (IH). 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%.
|
Control (CON) Intermittent Hypoxia
This arm of non injured control subjects will receive Intermittent Hypoxia (IH).
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%.
|
Spinal Cord Injury (SCI) SHAM
n=2 Participants
This arm of individuals with SCI will receive SHAM. 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).
|
Control (CON) SHAM
This arm of non injured control subjects will receive SHAM. 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).
|
|---|---|---|---|---|
|
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
|
—
|
1.60 IR Score
Standard Deviation 1.27
|
—
|
SECONDARY outcome
Timeframe: Baseline, day 5Change 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).
Outcome measures
| Measure |
Spinal Cord Injury (SCI) Intermittent Hypoxia
n=2 Participants
This arm of individuals with SCI will receive Intermittent Hypoxia (IH). 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%.
|
Control (CON) Intermittent Hypoxia
n=1 Participants
This arm of non injured control subjects will receive Intermittent Hypoxia (IH).
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%.
|
Spinal Cord Injury (SCI) SHAM
n=2 Participants
This arm of individuals with SCI will receive SHAM. 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).
|
Control (CON) SHAM
n=1 Participants
This arm of non injured control subjects will receive SHAM. 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).
|
|---|---|---|---|---|
|
Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test
|
63.2 % of total energy expenditure.
Standard Deviation 25.7
|
64.9 % of total energy expenditure.
Standard Deviation 8.4
|
51.4 % of total energy expenditure.
Standard Deviation 23.6
|
70.9 % of total energy expenditure.
Standard Deviation 3.8
|
Adverse Events
Spinal Cord Injury (SCI) Intermittent Hypoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (CON) Intermittent Hypoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Spinal Cord Injury (SCI) SHAM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (CON) SHAM.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place