Recruiting
IH, Brain Health, and T2D
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).
ClinicalTrials.gov IDNCT07173543
PhaseNA
Enrollment80
SponsorDarren P Casey
Age60 Years
SexALL
Conditions studied
Type 2 Diabetes, Aging
About this study
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).
Interventions
- Other: 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
- Other: 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
- Other: SHAM - normoxia — Participants will receive normoxia (no hypoxia) over 50 minutes.
Primary outcomes
- Internal Carotid Artery (ICA) shear-mediated dilation (Baseline and post 2-,4-,5-,6-, and 8-weeks)
- Cerebral blood flow responsiveness (Baseline and after 50 minutes of IH or SHAM)
- Cognitive function testing (Baseline and post 4- and 8-weeks)
Eligibility information
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 locations
- University of Iowa, Iowa City, Iowa 52242 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.