Intermittent hypoxia to improve brain blood flow in older adults with type 2 diabetes
Intermittent Hypoxia Training and Cerebrovascular Health in Older Adults With Type 2 Diabetes
This trial will test whether brief, repeated bouts of lower oxygen (intermittent hypoxia) can improve brain blood flow and cognition in adults aged 60–85 with type 2 diabetes, compared with non-diabetic older adults and a sham (normoxia) control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT07173543 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 60–85 with documented type 2 diabetes for at least one year, HbA1c between 6.5% and 10.0%, BMI ≤40 kg/m2, MoCA score ≥26, and without recent cardiovascular events, uncontrolled hypertension, obstructive sleep apnea, significant pulmonary or renal disease, dementia, or recent smoking are ideal candidates.
Not a fit: People with recent heart attack or stroke, symptomatic coronary disease or heart failure, uncontrolled blood pressure, obstructive sleep apnea, advanced lung or kidney disease, dementia, very poor glycemic control, or recent smokers are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, this could provide a non-drug approach to improve cerebral blood flow and potentially slow cognitive decline in older adults with type 2 diabetes.
How similar studies have performed: Animal studies and small human pilot studies provide preliminary evidence that intermittent hypoxia can improve vascular function, but large randomized evidence in older adults with type 2 diabetes is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Darren Casey, PHD
- Email: darren-casey@uiowa.edu
- Phone: 13193841009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.