- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02513641
Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes (SLEEPDM)
September 14, 2020 updated by: Eric Ravussin, Pennington Biomedical Research Center
Effect of 2-Week Nightly Moderate Hypoxia on Oral Glucose Tolerance in Individuals With Type 2 Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Baton Rouge, Louisiana, United States, 70809
- Pennington Biomedical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Sensitivity
Time Frame: 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.
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Baseline and Post-Moderate Hypoxia (14 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Secretion
Time Frame: 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.
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Baseline and Post-Moderate Hypoxia (14 days)
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Beta-cell Function
Time Frame: Baseline and Post-Moderate Hypoxia (14 days)
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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).
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Baseline and Post-Moderate Hypoxia (14 days)
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2-hour Glucose Area-under-the-curve
Time Frame: 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)
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2-hour glucose area-under-the-curve (mg/dL x hour) was determined using an oral glucose tolerance test.
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0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)
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2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test
Time Frame: 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)
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2-hour insulin area-under-the-curve (μU/mL x hr) was determined using an oral glucose tolerance test.
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0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
July 28, 2015
First Submitted That Met QC Criteria
July 30, 2015
First Posted (Estimate)
July 31, 2015
Study Record Updates
Last Update Posted (Actual)
October 12, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2015-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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