Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05643768
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with type 2 diabetes by physician
* fasting plasma glucose levels ≥126 mg/dl and ≤240 mg/dl
* systolic blood pressure between 120-169 mmHg
* stable dose of medication (three months on the same dose)
* weight stable in the prior 3 months (\<3.0 kg weight change) and willing to remain weight stable throughout the study
* absence of unstable clinical disease as determined by medical history
Exclusion Criteria:
* current smoker (including tobacco products, vaping devices, THC, etc…)
* have an uncontrolled medical condition (e.g., cancer)
* myocardial infarction or stroke within the previous 12 months
* performs regular aerobic exercise (\>4 bouts/week)
* BMI ≥ 40 kg/m2
* systolic blood pressure \<120 or ≥170 mmHg
* diastolic blood pressure \>100 or \<60 mmHg
* Cheyne-Stokes respiration
* history of perforated eardrum
* history of glaucoma or retinopathy
* history of collapsed lung
* diagnosed with asthma
* pregnant, breastfeeding, or trying to become pregnant (self-reported)
* medications that, in the opinion of the study physician or nurse practitioner, may impact the outcomes of the study (e.g., steroids)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05643768
Study Brief:
Protocol Section:
NCT05643768