Status:
RECRUITING
IH, Brain Health, and T2D
Lead Sponsor:
Darren P Casey
Collaborating Sponsors:
American Diabetes Association
Conditions:
Type 2 Diabetes
Aging
Eligibility:
All Genders
60-85 years
Phase:
NA
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 o...
Detailed Description
Aging is considered a major risk factor for the development of various cardio- and cerebrovascular related diseases, with vascular endothelial dysfunction representing one of the earliest vascular com...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07173543
Start Date
September 22 2025
End Date
June 30 2028
Last Update
September 22 2025
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242