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IH, Brain Health, and T2D

Intermittent Hypoxia Training and Cerebrovascular Health in Older Adults With Type 2 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether intermittent hypoxia (short periods of low oxygen) can improve blood vessel health in the brain. It compares this treatment with a placebo (an inactive treatment) in adults ages 60 to 85, with and without type 2 diabetes.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 60 to 85 years old.
  • Be willing and able to sign a consent form after the study is explained and before any study procedures.
  • Score 26 or higher on the MoCA, a test of memory and thinking.
  • For the diabetes group: have documented type 2 diabetes. The study will include 30 people with type 2 diabetes and 30 people without diabetes.

Who can't join

  • For the diabetes group: diagnosed less than 1 year ago, or HbA1c (a measure of average blood sugar) below 6.5% or above 10.0%. For the group without diabetes: any type 1 or type 2 diabetes.
  • Body mass index (BMI), a measure of weight compared with height, above 40.
  • Heart attack or stroke in the past year, heart artery disease that causes symptoms, or heart failure.
  • High blood pressure that is not controlled.
  • Obstructive sleep apnea (blocked breathing during sleep) or lung disease.
  • Dementia, a condition that affects memory and thinking.
  • Reduced kidney function, with an eGFR (kidney filtering test) below 60 ml/min.
  • Smoking now or within the past year.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (1)

IA