Type 2 DiabetesSLEEPDMNCT02513641
Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes
A study testing Hypoxico Altitude Training Systems in people with Type 2 Diabetes, run by Pennington Biomedical Research Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Hypoxico Altitude Training Systems
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Hypoxico Altitude Training Systems
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxico Altitude Training SystemsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hypoxico Altitude Training Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Post-Moderate Hypoxia (14 days)
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2018
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
- Investigators
- Eric Ravussin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513641
- Sponsor's protocol ID
- PBRC 2015-018
- Acronym
- SLEEPDM
- Status last verified
- Sep 2020
- First submitted
- 28 Jul 2015
- Last updated
- 12 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 2-Week Nightly Moderate Hypoxia on Oral Glucose Tolerance in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02513641
- Acronym / sponsor ID
- SLEEPDM / PBRC 2015-018
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Posted 30 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate Hypoxia | Experimental | Device: Hypoxico Altitude Training Systems2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- Diagnosed with T2DM ≥ 15 years ago
- Pregnant Women
- Current insulin treatment
- Treatment with sulfonylureas or glitinides
- Treatment with a GLP-1 agonist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxico Altitude Training SystemsParticipants 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. | Device | Moderate Hypoxia |
Primary outcome
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.
4 secondary outcomes
Insulin Secretion
Time frame: Baseline and Post-Moderate Hypoxia (14 days)
Beta-cell Function
Time frame: Baseline and Post-Moderate Hypoxia (14 days)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Ravussin, PhD principal investigator
Pennington Biomedical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxico Altitude Training Systems in people with Type 2 Diabetes, run by Pennington Biomedical Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Baseline and Post-Moderate Hypoxia (14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.