Intermittent hypoxia to improve brain blood flow in older adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled interventional study comparing two intermittent hypoxia protocols to a sham normoxia condition in older adults with and without type 2 diabetes. Approximately 30 participants with documented T2D and 30 non-diabetic control subjects, all aged 60–85 and cognitively intact (MoCA ≥26), will undergo supervised intermittent hypoxia sessions and serial measurements of cerebrovascular function and cognitive performance. Key exclusion criteria include recent cardiovascular events, symptomatic coronary disease or heart failure, uncontrolled hypertension, obstructive sleep apnea, significant pulmonary or renal disease, active smoking, and dementia. Safety monitoring and standardized physiological assessments will be used to track tolerability and changes in cerebral perfusion and cognitive endpoints.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Study coordinator: Darren Casey, PHD
• Email: darren-casey@uiowa.edu
• Phone: 13193841009

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.