IH, Brain Health, and T2D
Recruiting · NCT07173543 · Interventional (participants receive a specific treatment) · Lead sponsor: Darren P Casey
View the official record on ClinicalTrials.gov →Interventions studied
Intermittent Hypoxia 1 (IH1)Intermittent Hypoxia 2 (IH2)SHAM - normoxia
What this trial is about
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).
Who can take part
Age range
60 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- 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 is running
1 location listed across 1 US state.
- University of Iowa - Iowa City, Iowa, United States