Trial Outcomes & Findings for Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes (NCT NCT02513641)
NCT ID: NCT02513641
Last Updated: 2020-10-12
Results Overview
Insulin sensitivity was determined using an oral glucose tolerance test. Insulin sensitivity was estimated using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index (unitless): WBISI = 10,000 / \[square root of (Glu0 x Ins0) x (mean glucose x mean insulin during an oral glucose tolerance test)\] where Glu0 and Ins0 denote baseline glucose and insulin concentrations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Baseline and Post-Moderate Hypoxia (14 days)
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
Moderate Hypoxia
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Moderate Hypoxia
n=8 Participants
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
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|---|---|
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Age, Continuous
|
49 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight, Continuous
|
117.8 kg
STANDARD_DEVIATION 18.6 • n=5 Participants
|
|
Body mass index, Continuous
|
39.6 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Percent body fat, Continuous
|
43 percent
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Fat mass, Continuous
|
50.5 kg
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Fat-free mass, Continuous
|
67.3 kg
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Systolic blood pressure, Continuous
|
121 mmHg
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Diastolic blood pressure, Continuous
|
74 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Hemoglobin A1C, Continuous
|
6.8 percent
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Total cholesterol (TC), Continuous
|
170 mg/dL
STANDARD_DEVIATION 36 • n=5 Participants
|
|
High-density lipoprotein cholesterol (HDL), Continuous
|
55 mg/dL
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Low-density lipoprotein cholesterol (LDL), Continuous
|
95 mg/dL
STANDARD_DEVIATION 22 • n=5 Participants
|
|
Triglycerides, Continuous
|
100 mg/dL
STANDARD_DEVIATION 39 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Post-Moderate Hypoxia (14 days)Insulin sensitivity was determined using an oral glucose tolerance test. Insulin sensitivity was estimated using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index (unitless): WBISI = 10,000 / \[square root of (Glu0 x Ins0) x (mean glucose x mean insulin during an oral glucose tolerance test)\] where Glu0 and Ins0 denote baseline glucose and insulin concentrations.
Outcome measures
| Measure |
Moderate Hypoxia
n=8 Participants
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
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|---|---|
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Insulin Sensitivity
Post-Moderate Hypoxia Measure
|
2.2 unitless
Standard Deviation 1.7
|
|
Insulin Sensitivity
Baseline Measure
|
1.7 unitless
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline and Post-Moderate Hypoxia (14 days)Insulin secretion was determined using an oral glucose tolerance test. Insulin secretion was estimated using the Insulinogenic Index (IGI), an index of first-phase insulin response, and calculated from the ratio of the increments of serum insulin to glucose measured at 30 minutes: IGI (unitless) = (Ins30 - Ins0)/(Glu30 - Glu0), where insulin and glucose from 0 and 30 minutes are used.
Outcome measures
| Measure |
Moderate Hypoxia
n=8 Participants
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
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|---|---|
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Insulin Secretion
Baseline Measure
|
0.6 unitless
Standard Deviation 0.6
|
|
Insulin Secretion
Post-Moderate Hypoxia Measure
|
0.7 unitless
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline and Post-Moderate Hypoxia (14 days)Beta-cell function was determined using an oral glucose tolerance test. Beta-cell function was estimated by the Disposition Index, or the product of insulin sensitivity and insulin secretion: DI (unitless) = Matsuda Index (WBISI) x Insulinogenic Index (IGI).
Outcome measures
| Measure |
Moderate Hypoxia
n=8 Participants
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
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|---|---|
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Beta-cell Function
Baseline Measure
|
0.9 unitless
Standard Deviation 1.0
|
|
Beta-cell Function
Post-Moderate Hypoxia Measure
|
1.4 unitless
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)2-hour glucose area-under-the-curve (mg/dL x hour) was determined using an oral glucose tolerance test.
Outcome measures
| Measure |
Moderate Hypoxia
n=8 Participants
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
|
|---|---|
|
2-hour Glucose Area-under-the-curve
Post-Moderate Hypoxia Measure
|
439 mg/dL x hour
Standard Deviation 65
|
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2-hour Glucose Area-under-the-curve
Baseline Measure
|
501 mg/dL x hour
Standard Deviation 99
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)2-hour insulin area-under-the-curve (μU/mL x hr) was determined using an oral glucose tolerance test.
Outcome measures
| Measure |
Moderate Hypoxia
n=8 Participants
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
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|---|---|
|
2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test
Baseline Measure
|
180 uU/mL x hour
Standard Deviation 154
|
|
2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test
Post-Moderate Hypoxia Measure
|
168 uU/mL x hour
Standard Deviation 176
|
Adverse Events
Moderate Hypoxia
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moderate Hypoxia
n=8 participants at risk
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.
Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
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|---|---|
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Psychiatric disorders
Feelings of depression
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12.5%
1/8 • Number of events 1 • Approximately 1-month (baseline screening to end of 2-week moderate hypoxia exposure)
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Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
12.5%
1/8 • Number of events 1 • Approximately 1-month (baseline screening to end of 2-week moderate hypoxia exposure)
|
Additional Information
Dr. Eric Ravussin
Pennington Biomedical Research Center
Phone: 225-763-3186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place