RecruitingNot ApplicableNCT07173543

IH, Brain Health, and T2D

Intermittent Hypoxia Training and Cerebrovascular Health in Older Adults With Type 2 Diabetes


Sponsor

Darren P Casey

Enrollment

80 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Inclusion Criteria8

  • For 30 patients with documented Type 2 diabetes
  • 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
  • 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 Criteria22

  • 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.
  • 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

Interventions

OTHERIntermittent 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

OTHERIntermittent 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

OTHERSHAM - normoxia

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


Locations(1)

University of Iowa

Iowa City, Iowa, United States

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NCT07173543


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