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The purpose of this study is to determine if 2 weeks of nightly exposure (7-12 hours per night) to moderate hypoxia (~2,400 meters or 7,500 feet) improves glucose metabolism in people with type 2 diabetes.
Exposure to hypoxia has been advocated as a possible therapeutic aid against obesity. Indeed, our laboratory has provided the first evidence that intermittent, nightly exposure to moderate hypoxia is beneficial in improving insulin sensitivity in healthy obese patients and, therefore, lowers the risk of developing type 2 diabetes. Benefits included reduced fasting glucose levels and improved whole-body (skeletal muscle) and hepatic insulin sensitivity. Whether such intermittent hypoxia improves glucose metabolism in people with type 2 diabetes is unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hypoxia | Experimental | 2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoxico Altitude Training Systems | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | 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. | Baseline and Post-Moderate Hypoxia (14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion | 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. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Ravussin, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Pennington Biomedical Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity | 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. | Posted | Mean | Standard Deviation | unitless | Baseline and Post-Moderate Hypoxia (14 days) |
|
Approximately 1-month (baseline screening to end of 2-week moderate hypoxia exposure)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feelings of depression | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Ravussin | Pennington Biomedical Research Center | 225-763-3186 | eric.ravussin@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2017 | Oct 11, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2017 | Oct 11, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Baseline and Post-Moderate Hypoxia (14 days) |
| Beta-cell Function | 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). | Baseline and Post-Moderate Hypoxia (14 days) |
| 2-hour Glucose Area-under-the-curve | 2-hour glucose area-under-the-curve (mg/dL x hour) was determined using an oral glucose tolerance test. | 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days) |
| 2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test | 2-hour insulin area-under-the-curve (μU/mL x hr) was determined using an oral glucose tolerance test. | 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days) |
| Baton Rouge |
| Louisiana |
| 70809 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight, Continuous | Mean | Standard Deviation | kg |
|
| Body mass index, Continuous | Mean | Standard Deviation | kg/m^2 |
|
| Percent body fat, Continuous | Mean | Standard Deviation | percent |
|
| Fat mass, Continuous | Mean | Standard Deviation | kg |
|
| Fat-free mass, Continuous | Mean | Standard Deviation | kg |
|
| Systolic blood pressure, Continuous | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure, Continuous | Mean | Standard Deviation | mmHg |
|
| Hemoglobin A1C, Continuous | Mean | Standard Deviation | percent |
|
| Total cholesterol (TC), Continuous | Mean | Standard Deviation | mg/dL |
|
| High-density lipoprotein cholesterol (HDL), Continuous | Mean | Standard Deviation | mg/dL |
|
| Low-density lipoprotein cholesterol (LDL), Continuous | Mean | Standard Deviation | mg/dL |
|
| Triglycerides, Continuous | Mean | Standard Deviation | mg/dL |
|
|
|
| Secondary | Insulin Secretion | 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. | Posted | Mean | Standard Deviation | unitless | Baseline and Post-Moderate Hypoxia (14 days) |
|
|
|
| Secondary | Beta-cell Function | 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). | Posted | Mean | Standard Deviation | unitless | Baseline and Post-Moderate Hypoxia (14 days) |
|
|
|
| Secondary | 2-hour Glucose Area-under-the-curve | 2-hour glucose area-under-the-curve (mg/dL x hour) was determined using an oral glucose tolerance test. | Posted | Mean | Standard Deviation | mg/dL x hour | 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days) |
|
|
|
| Secondary | 2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test | 2-hour insulin area-under-the-curve (μU/mL x hr) was determined using an oral glucose tolerance test. | Posted | Mean | Standard Deviation | uU/mL x hour | 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| Cold symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |