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Recruiting NCT07173543

NCT07173543 IH, Brain Health, and T2D

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Clinical Trial Summary
NCT ID NCT07173543
Status Recruiting
Phase
Sponsor Darren P Casey
Condition Type 2 Diabetes
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2025-09-22
Primary Completion 2028-06-30

Trial Parameters

Condition Type 2 Diabetes
Sponsor Darren P Casey
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 60 Years
Max Age 85 Years
Start Date 2025-09-22
Completion 2028-06-30
Interventions
Intermittent Hypoxia 1 (IH1)Intermittent Hypoxia 2 (IH2)SHAM - normoxia

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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).

Eligibility 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 expla

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