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CompletedNCT05898685Updated Jun 12, 2023

Effect of a Single Session of Intermittent Hypoxia on Hematological Variables

An interventional study of Intermittent hypoxia and Intermittent normoxia in Intermittent Hypoxia, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Apr 2019, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Intermittent Hypoxia
03

In context

Lead sponsor

University of Texas at Austin is the lead sponsor of 326 studies on the registry; 79 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

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

Study arms

  • Experimental
    Intermittent hypoxia

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

    Behavioral: Intermittent hypoxia

  • Sham comparator
    Intermittent normoxia

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

    Behavioral: Intermittent normoxia

Interventions

  • BehavioralIntermittent hypoxia

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

  • BehavioralIntermittent normoxia

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

06

What researchers measure

Primary outcomes

  1. Change in erythropoietin levels

    Hormone that regulates red blood cell production

    Time frame: Measured before and 4.5 hours after intermittent hypoxia

07

Study locations

1 site
  • The Unviersity of Texas at Austin
    Austin, Texas 78712, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05898685
Responsible party
Sophie Lalande (Assistant Professor, University of Texas at Austin) — Principal investigator
First posted
Jun 12, 2023
Start date
Apr 16, 2019
Primary completion
Nov 20, 2022
Completion
Apr 1, 2023
Last update
Jun 12, 2023

Oversight

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

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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