NCT07173543

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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
25mo left

Started Sep 2025

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress26%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

September 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

September 2, 2025

Last Update Submit

March 12, 2026

Conditions

AgingType 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Internal Carotid Artery (ICA) shear-mediated dilation

    ICA dilation (% change) will be determined using Doppler ultrasound in response to acute hypercapnia.

    Baseline and post 2-,4-,5-,6-, and 8-weeks

  • Cerebral blood flow responsiveness

    Cerebral blood flow will be determined using Doppler ultrasound in response to acute hypoxia.

    Baseline and after 50 minutes of IH or SHAM

  • Cognitive function testing

    Working memory will be assessed using a facial recognition n-back task test

    Baseline and post 4- and 8-weeks

Study Arms (3)

Intermittent Hypoxia 1

EXPERIMENTAL

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

Other: Intermittent Hypoxia 1 (IH1)

Normoxia

SHAM COMPARATOR

Participants will receive normoxia over 50 minutes.

Other: SHAM - normoxia

Intermittent Hypoxia 2

EXPERIMENTAL

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

Other: Intermittent Hypoxia 2 (IH2)

Interventions

Intermittent Hypoxia 1 (IH1)OTHER

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

Intermittent Hypoxia 1
Intermittent Hypoxia 2 (IH2)OTHER

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

Intermittent Hypoxia 2
SHAM - normoxiaOTHER

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

Normoxia

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • nondiabetic control subjects will also be studied.
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Darren Casey, PHD

CONTACT

13193841009darren-casey@uiowa.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 15, 2025

Study Start

September 22, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

US(1)