Recruiting

Intermittent Hypoxia

Sponsor:

Darren P Casey

Code:

NCT07173543

Conditions

Type 2 Diabetes

Aging

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Intermittent Hypoxia 1 (IH1)

Intermittent Hypoxia 2 (IH2)

SHAM - normoxia

Study Details

Brief summary:

The purpose of this study is to use a randomized, placebo-controlled study design to rigorously examine the therapeutic potential of intermittent hypoxia (IH) for improving cerebrovascular health in older adults with and without type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes

Aging

Study ID

NCT07173543

Start date

Sep 22, 2025

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

For 30 patients with documented Type 2 diabetes

Inclusion Criteria:

  • Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
  • Age is > or = 60 and < or = 85 years of age
  • Documented Type 2 diabetes
  • Scoring 26 or higher on the MoCA test

Exclusion criteria:

  • diagnosis of type 2 diabetes < 1 year prior to enrollment
  • HbA1c <6.5% or >10.0%
  • body mass index > 40 kg/m 2
  • incident cardiovascular events in the last year (heart attack, stroke)
  • symptomatic coronary artery disease and/or heart failure
  • uncontrolled hypertension
  • obstructive sleep apnea
  • pulmonary disease
  • dementia
  • renal impairment with creatinine clearance (eGFR) of <60 ml/min
  • smoking or history of smoking within past one year

30 nondiabetic control subjects will also be studied.

Inclusion criteria:

  • Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
  • Age is > or = 60 and < or = 85 years of age
  • Scoring 26 or higher on the MoCA test

Exclusion criteria:

  • Diagnosis of diabetes (Type 1 or Type 2)
  • body mass index > 40 kg/m2
  • incident cardiovascular events in the last year (heart attack, stroke)
  • symptomatic coronary artery disease and/or heart failure
  • uncontrolled hypertension
  • obstructive sleep apnea
  • pulmonary disease
  • dementia
  • renal impairment with creatinine clearance (eGFR) of <60 ml/min
  • smoking or history of smoking within past one year

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intermittent Hypoxia 1

Participants will receive intermittent hypoxia (5 cycles of normoxia/hypoxia over 50 minutes).

sham comparator: Normoxia

Participants will receive normoxia over 50 minutes.

experimental: Intermittent Hypoxia 2

Participants will receive intermittent hypoxia (5 cycles of normoxia/hypoxia over 50 minutes).

Interventions

Intermittent Hypoxia 1 (IH1)

Intermittent Hypoxia 1 (IH1): 5 cycles of normoxia (4 minutes)/hypoxia (6 minutes) per session. 3 sessions per week for 8 weeks

Intermittent Hypoxia 2 (IH2)

Intermittent Hypoxia 1 (IH2): 5 cycles of normoxia (4 minutes)/hypoxia (6 minutes) per session. 3 sessions per week for 4 weeks

SHAM - normoxia

Participants will receive normoxia (no hypoxia) over 50 minutes.

Primary outcome measure

  • Internal Carotid Artery (ICA) shear-mediated dilation [ Time Frame: Baseline and post 2-,4-,5-,6-, and 8-weeks ]
  • Cerebral blood flow responsiveness [ Time Frame: Baseline and after 50 minutes of IH or SHAM ]
  • Cognitive function testing [ Time Frame: Baseline and post 4- and 8-weeks ]

Central Contacts and Locations

Central contacts

Darren Casey, PHD

13193841009darren-casey@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Darren P Casey, PhD

More Information

Sponsor

Darren P Casey

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Darren P Casey on 2026-03-13.