Influence of Intermittent Hypoxia on Glycemic Control
Influence of One Session of Intermittent Hypoxia on Glycemic Control
1 other identifier
interventional
18
1 country
1
Brief Summary
The aim of this research project is to determine the effect of intermittent hypoxia on glucose uptake in response to an oral glucose tolerance test in healthy individuals, individuals with prediabetes 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 below P25 for not_applicable
Started Feb 2021
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
February 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2024
CompletedFirst Submitted
Initial submission to the registry
June 29, 2024
CompletedFirst Posted
Study publicly available on registry
July 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2024
CompletedMarch 25, 2025
March 1, 2025
3.1 years
June 29, 2024
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in plasma glucose levels
Plasma glucose levels obtained from a venous catheter during a 2-hour oral glucose tolerance test
Collected at minutes 0, 30, 60, 90 and 120 of the oral glucose tolerance test
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 (room air) 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 (room air) 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
You may not qualify if:
- Have uncontrolled stage 2 hypertension (˃140/90 mmHg)
- Are smokers
- Are pregnant
- Have a history of cardiovascular disease or indication of cardiovascular disease such as myocardial infarction, left ventricular hypertrophy, ischemic heart disease (or prior ischemia), stroke, and/or other vascular disease
- Have a history of lung disease
- 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie Lalande
UT Austin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 29, 2024
First Posted
July 8, 2024
Study Start
February 5, 2021
Primary Completion
March 3, 2024
Study Completion
November 26, 2024
Last Updated
March 25, 2025
Record last verified: 2025-03