ClinicalTrials.gg
SuspendedNCT03408613OSAGMUpdated May 8, 2026

Obstructive Sleep Apnea and Glucose Metabolism

An interventional study of Positive Airway Pressure and Supplemental Oxygen in Sleep Apnea and Glucose Metabolism Disorders, sponsored by University of Missouri-Columbia. Suspended at 1 site in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

Primary conditionSleep Apnea, ObstructiveRegistry: Sleep Apnea SyndromesReclassifiedWhy we changed it
Registry
Sleep Apnea Syndromes — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sleep Apnea, Obstructive
Why
  1. The study's title name Sleep Apnea, Obstructive, a narrower term within Sleep Apnea Syndromes.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment

Why this study was suspended
equipment recall

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 753 studies in Sleep Apnea, Obstructive with a site in United States — 126 open to participants now, 160 under way, 9 of them phase 3. Sleep Apnea, Obstructive · United States.

Planned enrollment
194th of 594
80 · median 49
Started
2018
with 27 others
No phase
410 of 753
66 open now
Registered
410th of 753
by date

Among the 753 studies in Sleep Apnea, Obstructive with a site in United States, this one is the 194th largest by planned enrollment of the 594 interventional ones that give a count, is one of 28 that started in 2018, is one of 410 with no phase, and was the 410th registered.

Sleep Apnea, Obstructive

2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

Browse Sleep Apnea, Obstructive studies →

Open to participants now

126 of the 753 studies in Sleep Apnea, Obstructive with a site in United States are open now. Recruiting first, the newest first:

121 more — sign in →

All 126 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.

This study: 30 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 753 studies in Sleep Apnea, Obstructive with a site in United States, or all of them as a file.
02

Study summary

Many adults who are overweight have obstructive sleep apnea (OSA) which disrupts sleep and makes it difficult to breath during the night. OSA increases the risk for a person to become insulin resistant and diabetic. It is not known why OSA causes this problem, i.e., whether it is disrupted sleep or lack of oxygen., which can change how the body handles glucose in adipose tissue, muscle tissue and liver.

The purpose of this research study is to determine the key issues and mechanisms responsible for dysregulated glucose metabolism in people with OSA. The investigators will do this by comparing glucose metabolism in people who have OSA, and those who do not, and by evaluating the effect of treating OSA by providing continuous positive airway pressure (CPAP) or simply oxygen during the night.

The proposed study will evaluate the primary causes(s) (hypoxia, sleep fragmentation, or both) and pathophysiological mechanisms responsible for the OSA-associated metabolic abnormalities. Knowing the primary cause of Obstructive Sleep Apnea and pathophysiological mechanisms responsible for the OSA-associated metabolic abnormalities could help develop potentially novel therapeutic strategies to provide treatment for adults in improving OSA and associated comorbidities.

03

Conditions studied

  • Sleep Apnea
  • Glucose Metabolism Disorders

Browse trials for

Keywords

  • Obstructive Sleep Apnea
  • Glucose Metabolism
04

In context

Sleep Apnea, Obstructive Reclassified

2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 80 is above the median of 52 across 1,474 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.

Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.

Compared within Sleep Apnea, Obstructive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sleep Apnea Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

General Inclusion Criteria (for all subjects):

  • Age: ≥30 and ≤70 years,
  • : ≥30 and ≤45 kg/m2 or body fat ≥ 30 % for women and ≥ 25 % for men,
  • Maximum body circumference \<170 cm
  • Weight stable (≤2% change)
  • Untrained (≤1 h of structured exercise/wk) for at least 3 months before entering the study
  • No diabetes (fasting blood glucose \<126 mg/dl, 2h oral glucose tolerance test (OGTT) glucose \<200 mg/dl, ≤6.5%)

Sleep-related inclusion criteria:

Subjects without OSA:

  • AHI \<5/h of sleep;
  • Oxygen desaturation index \<3/h
  • No known sleep disorders and periodic limb movement arousal index \<15/h during polysomnography
  • Reported sleep duration ≥6 h per night
  • Regular sleep schedules (i.e. bedtime between 8 pm and 12 am and wake-time between 4 am and 8 am on all days of the week)

Subjects with OSA

  • AHI ≥10/h of sleep (i.e., moderate to severe OSA)
  • Oxygen desaturation index ≥4/h;
  • No polysomnogram finding that would trigger immediate PAP treatment as per standard operating protocol in our sleep medicine center (a single SaO2 \<50%, SaO2 \<70% for >2 minutes, pause >5 sec, or ventricular tachycardia >30 sec), because of the risk of a potentially adverse outcome if they are not randomized to the PAP group
  • Periodic limb movement arousal index \<15/h during polysomnography,
  • Reported sleep duration ≥6 h per night,
  • Regular night-time sleep schedules, defined as bedtime between 8 pm and 12 am and wake-time between 4 am and 8 am on all days of the week.

General Exclusion Criteria (for all subjects):

  • Current treatment for previously diagnosed OSA;
  • Self-reported severe difficulty sleeping in unfamiliar environments;
  • Metal implants that are incompatible with magnetic resonance imaging;
  • Controlled substances, tobacco products, dietary supplements, or medications known or suspected to affect sleep, breathing, upper airway muscle physiology, or glucose metabolism
  • Evidence of disease (e.g., diabetes, congestive heart failure; ; hypoventilation, defined as daytime partial pressure of carbon dioxide (pCO2) >45 mm Hg; major neurological or neuromuscular disorders; cancer; uncontrolled hypertension; etc.);
  • to supplemental oxygen or PAP (e.g., recent trans-sphenoidal surgery).
  • Unwillingness or inability to provide
  • Study physician considers subject to be unable to safely complete the study protocol
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Positive Airway Pressure (PAP)

    A registered polysomnographic technologist will perform a titration starting at 4 cm water (H2O) and adjust this value as needed to identify the optimal pressure to achieve an Apnea Hypopnea Index (AHI) \<5 (including rapid eye movement sleep in the supine position). After PAP titration, subjects will be instructed to use the machine at the optimal pressure every night for 3 months. Compliance will be defined as: ≥4 hours use on 70% of nights and average use ≥6 hours per night.

    Procedure: Positive Airway Pressure

  • Experimental
    Supplemental Oxygen (O2)

    Subjects randomized to night-time supplemental oxygen will complete an overnight oxygen titration protocol in the clinical research unit. Initially, subjects will receive 0.5 liters oxygen (O2)/min; the delivery rate will then be increased by 0.5 l/min until oxygen saturation (SaO2) is ≥88%. The optimal O2 delivery rate determined during this study will be used for the intervention. The oxygen concentrators used at home will record cumulative hours of use to provide an objective measure of adherence (monitored weekly). Compliance will be defined as ≥6 h average use per night..

    Procedure: Supplemental Oxygen

  • Sham comparator
    Sham

    Subjects in the sham treatment group will complete the oxygen titration protocol described for the night-time supplemental oxygen group, except that their oxygen concentrator will have been covertly modified to deliver room air at a rate of 0.5 l/min.

    Procedure: Sham

  • No intervention
    Controls

    Subjects without OSA will be recruited and complete all testing for primary outcome measures, but will not undergo any intervention.

Interventions

  • ProcedurePositive Airway Pressure

    See arm/group description

  • ProcedureSupplemental Oxygen

    See arm/group description

  • ProcedureSham

    See arm/group description

07

What researchers measure

Primary outcomes

  1. Insulin mediated glucose disposal

    The hyperinsulinemic-euglycemic clamp technique combined with isotope-labelled tracer infusions will be used to assess insulin mediated glucose rate of disappearance before and after treatment of OSA with three months of night-time supplemental oxygen, PAP, or sham.

    Time frame: 3 months

Secondary outcomes

  1. β-cell function

    β-cell responsivity to glucose and the disposition index will be determined to characterize the insulin secretory response to glucose infusion and the relationship between insulin secretion and insulin sensitivity. This outcome will be determined by using an insulin-modified intravenous glucose tolerance test in conjunction with mathematical modelling and insulin sensitivity data from the hyperinsulinemic clamp.

    Time frame: 3 months

  2. Tissue oxygenation

    Adipose and muscle tissue oxygenation, expressed as mmHg, will be evaluated in situ during the hyperinsulinemic-euglycemic clamp studies.

    Time frame: 3 months

  3. Body composition analysis

    Detailed body composition analysis using dual energy x-ray absorptiometry (DXA) will provide the researchers with total and appendicular lean body and fat mass, expressed in grams of participants.

    Time frame: 3 months

08

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
09

References and documents

Publications

  • Cao C, Koh HE, Van Vliet S, Patterson BW, Reeds DN, Laforest R, Gropler RJ, Mittendorfer B. Increased plasma fatty acid clearance, not fatty acid concentration, is associated with muscle insulin resistance in people with obesity. Metabolism. 2022 Jul;132:155216. doi: 10.1016/j.metabol.2022.155216. Epub 2022 May 13. PubMed 35577100 ↗
  • van Vliet S, Koh HE, Patterson BW, Yoshino M, LaForest R, Gropler RJ, Klein S, Mittendorfer B. Obesity Is Associated With Increased Basal and Postprandial beta-Cell Insulin Secretion Even in the Absence of Insulin Resistance. Diabetes. 2020 Oct;69(10):2112-2119. doi: 10.2337/db20-0377. Epub 2020 Jul 10. PubMed 32651241 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Feb 2027, 109 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2017
First posted
Jan 24, 2018
StartActual
Jan 17, 2018
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2028
Last update
May 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03408613
Responsible party
Bettina Mittendorfer (Senior Associate Dean for Research, University of Missouri-Columbia) — Principal investigator
First posted
Jan 24, 2018
Start date
Jan 17, 2018
Primary completion
Feb 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
May 8, 2026

Study contacts

Bettina Mittendorfer, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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