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Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes (SLEEPDM)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypoxico Altitude Training Systems
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA:

  • Aged 20-65 yrs
  • Body mass index (BMI) < 55 kg/m2
  • Body weight 450 lbs or less (to accommodate body composition assessment)
  • Have either been diagnosed with type 2 diabetes, or fasting blood glucose between 125 and 200 mg/dL, or have a hemoglobin A1c ≥ 6.5%
  • Non-smokers
  • Weight stable over the previous 3 months (<3 kg fluctuation)
  • Known diagnosis of sleep apnea and ownership of a continuous positive airway pressure (C-PAP) device that must be worn throughout the nights spent in the tent
  • If no known presence of sleep apnea, be willing to spend one night in a sleep laboratory (Louisiana Sleep Foundation) to assess presence of sleep apnea

EXCLUSION CRITERIA:

  • Diagnosed with T2DM ≥ 15 years ago
  • Pregnant Women
  • Current insulin treatment
  • Treatment with sulfonylureas or glitinides
  • Treatment with a GLP-1 agonist
  • Any other diabetes medication other than an oral agent is exclusionary unless otherwise cleared by medical investigator.
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive heart failure
  • Prior severe cardiovascular events such as stroke or myocardial infarction
  • If treated for T2DM with other oral agent, no change in the treatment for 1 month before the study and the duration of the study
  • Previously known diagnosis of sleep apnea without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned CPAP device during the nights spent in the tent
  • Presence of sleep apnea following a positive home sleep test (HST), or have unsafe oxyhemoglobin saturation levels (less than 78%) during a one night sleep monitoring assessment conducted at the Louisiana Sleep Foundation without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned C-PAP device during the nights spent in the tent
  • History of high altitude sickness
  • History of altitude sickness
  • Does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress

Sites / Locations

  • Pennington Biomedical Research Center
  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moderate Hypoxia

Arm Description

2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
July 28, 2015
Last Updated
September 14, 2020
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02513641
Brief Title
Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes
Acronym
SLEEPDM
Official Title
Effect of 2-Week Nightly Moderate Hypoxia on Oral Glucose Tolerance in Individuals With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Hypoxia
Arm Type
Experimental
Arm Description
2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device.
Intervention Type
Device
Intervention Name(s)
Hypoxico Altitude Training Systems
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
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.
Time Frame
Baseline and Post-Moderate Hypoxia (14 days)
Secondary Outcome Measure Information:
Title
Insulin Secretion
Description
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.
Time Frame
Baseline and Post-Moderate Hypoxia (14 days)
Title
Beta-cell Function
Description
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).
Time Frame
Baseline and Post-Moderate Hypoxia (14 days)
Title
2-hour Glucose Area-under-the-curve
Description
2-hour glucose area-under-the-curve (mg/dL x hour) was determined using an oral glucose tolerance test.
Time Frame
0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)
Title
2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test
Description
2-hour insulin area-under-the-curve (μU/mL x hr) was determined using an oral glucose tolerance test.
Time Frame
0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Aged 20-65 yrs Body mass index (BMI) < 55 kg/m2 Body weight 450 lbs or less (to accommodate body composition assessment) Have either been diagnosed with type 2 diabetes, or fasting blood glucose between 125 and 200 mg/dL, or have a hemoglobin A1c ≥ 6.5% Non-smokers Weight stable over the previous 3 months (<3 kg fluctuation) Known diagnosis of sleep apnea and ownership of a continuous positive airway pressure (C-PAP) device that must be worn throughout the nights spent in the tent If no known presence of sleep apnea, be willing to spend one night in a sleep laboratory (Louisiana Sleep Foundation) to assess presence of sleep apnea EXCLUSION CRITERIA: Diagnosed with T2DM ≥ 15 years ago Pregnant Women Current insulin treatment Treatment with sulfonylureas or glitinides Treatment with a GLP-1 agonist Any other diabetes medication other than an oral agent is exclusionary unless otherwise cleared by medical investigator. Chronic Obstructive Pulmonary Disease (COPD) Congestive heart failure Prior severe cardiovascular events such as stroke or myocardial infarction If treated for T2DM with other oral agent, no change in the treatment for 1 month before the study and the duration of the study Previously known diagnosis of sleep apnea without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned CPAP device during the nights spent in the tent Presence of sleep apnea following a positive home sleep test (HST), or have unsafe oxyhemoglobin saturation levels (less than 78%) during a one night sleep monitoring assessment conducted at the Louisiana Sleep Foundation without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned C-PAP device during the nights spent in the tent History of high altitude sickness History of altitude sickness Does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Ravussin, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States

12. IPD Sharing Statement

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Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes

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