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Intermittent HypoxiaNCT05898685

Effect of a Single Session of Intermittent Hypoxia on Hematological Variables

A study testing Intermittent hypoxia and Intermittent normoxia in people with Intermittent Hypoxia, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to determine the effect of a single exposure of intermittent hypoxia on erythropoietin levels and hemoglobin mass in young adults, older adults and patients with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Intermittent Hypoxia
What is being tested?
Intermittent hypoxia and Intermittent normoxia
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteUnited States
Study dates
16 Apr 2019to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women aged 18 to 80 years old
  • Adults with type 2 diabetes aged 30 to 80 years old

Who cannot join

  • Have high blood pressure (above 140/90 mmHg)
  • Are smokers
  • Are pregnant
  • Have a history of cardiovascular disease, diabetes or lung disease
  • Are taking more than one antihypertensive medication
  • Are taking insulin or more than one antihypertensive medication
  • Have poorly controlled diabetes: HbA1c levels ˃ 9%
  • Have been previously diagnosed with diabetic complications (nephropathy, neuropathy, retinopathy) by their family doctor

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Unviersity of Texas at Austin

    Austin, Texas, 78712

Other trials in United States

About this study

The purpose of the study is to determine the effect of a single exposure of intermittent hypoxia on erythropoietin levels and hemoglobin mass in young adults, older adults and patients with type 2 diabetes.

Read the detailed description

Cardiorespiratory fitness, assessed by measuring maximal oxygen consumption (VO2max), has a potential to predict cardiovascular disease and mortality risk to a greater extent than smoking, hypertension, type 2 diabetes or high cholesterol levels. Oxygen transport from the lungs to the exercising muscles is achieved through the binding of oxygen to hemoglobin, an iron-containing protein in the red blood cell. Therefore, hemoglobin mass represents the oxygen-carrying capacity of the blood and strongly correlates with VO2max. Patients with type 2 diabetes have serious impairments in cardiorespiratory fitness, as observed through a 20% lower VO2max than individuals matched for age, weight and physical activity levels. The investigators previously showed that a lower hemoglobin mass limits oxygen-carrying capacity and contributes to the lower VO2max in patients with type 2 diabetes. Thus, interventions that can increase hemoglobin mass should result in improved oxygen-carrying capacity and VO2max in patients with type 2 diabetes. While the majority of patients with type 2 diabetes are aware of their need to perform exercise to improve their VO2max, less than 1/3 of patients meet recommended levels of physical activity. There is therefore an urgent need to develop alternative interventions that improve VO2max, as even minimal improvements in VO2max significantly decrease mortality risk in unfit individuals.

Hypoxia deprives the body of adequate oxygen supply at the tissue level which stimulates the release of erythropoietin (EPO), the peptide hormone regulating red blood cell production, in order to restore oxygen supply to the tissues. Following a rise in EPO levels, it takes 5-6 days for a newly created reticulocyte to mature into a red blood cell, and to observe an increased hemoglobin mass. Increases in EPO levels have been observed to reach maximum values approximately 2-3 h after continuous hypoxic exposure lasting between 90 minutes and 3 hours. It has consequently been suggested that intermittent hypoxia, consisting of alternating few minutes of breathing hypoxic air with few minutes of breathing normoxic air, would provide a stimulus sufficient to stimulate an increase in EPO levels and hematological variables. Only one study measured both EPO levels and hematological changes in responses to intermittent hypoxia. Elite distance runners completed 4 weeks of intermittent hypoxia consisting of 5:5-minutes hypoxia-to-normoxia ratio for 70 min, 5 times/week. The fraction of inspired oxygen gradually declined from 0.12 to 0.10%. The authors did not observe any increase in EPO levels or hemoglobin concentration. However, there were several methodological limitations that could explain these findings. First, hemoglobin concentration is dependent on plasma volume and is therefore greatly influenced by hydration status, and correlates only to a modest extent with red blood cell mass. On the other hand, hemoglobin mass is reported in grams and is a more direct measure of oxygen-carrying capacity. Second, EPO measurements were performed at the same time of day to minimize any circadian variability in EPO levels, which likely prevented the detection of a rise in EPO within the first few hours following the exposure to intermittent hypoxia. Therefore, the purpose of the present study is to determine the effect of a single exposure of intermittent hypoxia on EPO levels and hemoglobin mass in healthy individuals. The cardiovascular and ventilatory responses to a single exposure of intermittent hypoxia will also be determined. If intermittent hypoxia improves oxygen-carrying capacity, the next step will be to apply this intervention to patients with type 2 diabetes.

Being tested
Intermittent hypoxia, Intermittent normoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent hypoxiaBehavioural

    The intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation.

  • Intermittent normoxiaBehavioural

    The intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air)

Study groups in NCT05898685
Study groupRoleWhat they receive
Intermittent hypoxiaExperimentalThe intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation.
Receives: Behavioral: Intermittent hypoxia
Intermittent normoxiaSham comparatorThe intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air).
Receives: Behavioral: Intermittent normoxia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in erythropoietin levels

    Hormone that regulates red blood cell production

    Measured: Measured before and 4.5 hours after intermittent hypoxia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start16 Apr 2019
  3. Primary completion20 Nov 2022
  4. Study completion1 Apr 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05898685
Sponsor's protocol ID
2017-09-0015
Status last verified
Jun 2023
First submitted
29 May 2023
Last updated
12 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wojan F, Stray-Gundersen S, Zhao J, Lalande S. Impaired erythropoietin response to hypoxia in type 2 diabetes. Acta Diabetol. 2024 Jul;61(7):925-932. doi: 10.1007/s00592-024-02269-2. Epub 2024 Apr 4.

    PubMed 38570345

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent hypoxia and Intermittent normoxia in people with Intermittent Hypoxia, run by University of Texas at Austin at 1 site 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 2 inclusion and 8 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in erythropoietin levels (time frame: Measured before and 4.5 hours after intermittent hypoxia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05898685, which also lists 1 linked publication.

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 Jun 2023.

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