NCT05422430

Brief Summary

The aim of this research project is to determine the effect of repeated maximal voluntary apneas on glucose uptake during an oral glucose tolerance test in healthy individuals, individuals with prediabetes and patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2025

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

May 8, 2022

Last Update Submit

May 5, 2026

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 min 0, 30, 60, 90 and 120 minutes of the oral glucose tolerance test

Study Arms (2)

Spontaneous breathing

SHAM COMPARATOR

Participants will be spontaneously breathing during an oral glucose tolerance test.

Behavioral: Spontaneous breathing

Rebreathing-induced hypoxia

EXPERIMENTAL

Participants will rebreathe room air from a low-volume closed-circuit system for a period of 2 minutes.

Behavioral: Rebreathing-induced hypoxia

Interventions

Participants will rebreathe room air from a low-volume closed-circuit system for a period of 2 minutes.

Rebreathing-induced hypoxia

Participants will be spontaneously breathing during an oral glucose tolerance test.

Spontaneous breathing

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (10)

  • Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010 Oct 22;8:29. doi: 10.1186/1478-7954-8-29.

    PMID: 20969750BACKGROUND
  • Resnick HE, Foster GL, Bardsley J, Ratner RE. Achievement of American Diabetes Association clinical practice recommendations among U.S. adults with diabetes, 1999-2002: the National Health and Nutrition Examination Survey. Diabetes Care. 2006 Mar;29(3):531-7. doi: 10.2337/diacare.29.03.06.dc05-1254.

    PMID: 16505501BACKGROUND
  • Azevedo JL Jr, Carey JO, Pories WJ, Morris PG, Dohm GL. Hypoxia stimulates glucose transport in insulin-resistant human skeletal muscle. Diabetes. 1995 Jun;44(6):695-8. doi: 10.2337/diab.44.6.695.

    PMID: 7789635BACKGROUND
  • Cartee GD, Douen AG, Ramlal T, Klip A, Holloszy JO. Stimulation of glucose transport in skeletal muscle by hypoxia. J Appl Physiol (1985). 1991 Apr;70(4):1593-600. doi: 10.1152/jappl.1991.70.4.1593.

    PMID: 2055841BACKGROUND
  • Mu J, Brozinick JT Jr, Valladares O, Bucan M, Birnbaum MJ. A role for AMP-activated protein kinase in contraction- and hypoxia-regulated glucose transport in skeletal muscle. Mol Cell. 2001 May;7(5):1085-94. doi: 10.1016/s1097-2765(01)00251-9.

    PMID: 11389854BACKGROUND
  • Louis M, Punjabi NM. Effects of acute intermittent hypoxia on glucose metabolism in awake healthy volunteers. J Appl Physiol (1985). 2009 May;106(5):1538-44. doi: 10.1152/japplphysiol.91523.2008. Epub 2009 Mar 5.

    PMID: 19265062BACKGROUND
  • Newhouse LP, Joyner MJ, Curry TB, Laurenti MC, Man CD, Cobelli C, Vella A, Limberg JK. Three hours of intermittent hypoxia increases circulating glucose levels in healthy adults. Physiol Rep. 2017 Jan;5(1):e13106. doi: 10.14814/phy2.13106. Epub 2017 Jan 13.

    PMID: 28087818BACKGROUND
  • Duennwald T, Gatterer H, Groop PH, Burtscher M, Bernardi L. Effects of a single bout of interval hypoxia on cardiorespiratory control and blood glucose in patients with type 2 diabetes. Diabetes Care. 2013 Aug;36(8):2183-9. doi: 10.2337/dc12-2113. Epub 2013 Mar 27.

    PMID: 23536585BACKGROUND
  • Costalat G, Lemaitre F, Tobin B, Renshaw G. Intermittent hypoxia revisited: a promising non-pharmaceutical strategy to reduce cardio-metabolic risk factors? Sleep Breath. 2018 Mar;22(1):267-271. doi: 10.1007/s11325-017-1459-8. Epub 2017 Feb 2.

    PMID: 28155101BACKGROUND
  • de Bruijn R, Richardson M, Schagatay E. Increased erythropoietin concentration after repeated apneas in humans. Eur J Appl Physiol. 2008 Mar;102(5):609-13. doi: 10.1007/s00421-007-0639-9. Epub 2007 Dec 19.

    PMID: 18097682BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sophie Lalande

    UT Austin

    PRINCIPAL INVESTIGATOR

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

May 8, 2022

First Posted

June 16, 2022

Study Start

October 21, 2021

Primary Completion

September 4, 2023

Study Completion

October 13, 2025

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations