Effect of a Single Session of Intermittent Hypoxia on Hematological Variables
1 other identifier
interventional
54
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 29, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedJune 12, 2023
June 1, 2023
3.6 years
May 29, 2023
June 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in erythropoietin levels
Hormone that regulates red blood cell production
Measured before and 4.5 hours after intermittent hypoxia
Study Arms (2)
Intermittent hypoxia
EXPERIMENTALThe intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation.
Intermittent normoxia
SHAM COMPARATORThe intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air).
Interventions
The intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation.
The intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air)
Eligibility Criteria
You may qualify if:
- Men and women aged 18 to 80 years old
- Adults with type 2 diabetes aged 30 to 80 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Unviersity of Texas at Austin
Austin, Texas, 78712, United States
Related Publications (1)
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.
PMID: 38570345DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 29, 2023
First Posted
June 12, 2023
Study Start
April 16, 2019
Primary Completion
November 20, 2022
Study Completion
April 1, 2023
Last Updated
June 12, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share