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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT04262128
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 60-75 years
* Postmenopausal (self-reported)
* BMI between 25-40 kg/m2
* Participants with T2D:
* T2D confirmed via chart review
* T2D diet controlled or treated with the following acceptable medication treatments: metformin, sulfonylureas, glinides, or glucose absorption blockers
Exclusion Criteria:
* Male
* Age \<60 or \>75 years
* Type 1 diabetes
* Control participants only - HbA1C ≥ 5.7%
* Use of beta blockers or centrally-acting calcium channel blockers (i.e., diltiazem, verapamil) due to potential blunting of cardiorespiratory fitness assessments
* Use of hormone replacement therapy (e.g., estrogen, progesterone, testosterone) (within the past 5 years)
* Taking insulin, thiazolidinediones (e.g., rosiglitazone), glucagon-like peptide-1 (GLP1) agonists (e.g., exenatide), dipeptidyl peptidase-4 (DPP4) inhibitors (e.g., sitagliptin) or any medication for the treatment of T2D other than those listed above in the inclusion criteria
* Uncontrolled hypertension at rest (systolic \>160 or diastolic \>110 mmHg)
* Obstructive pulmonary disease or asthma with a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio \<70% of predicted
* Any of the following conditions:
* Uncontrolled T2D (HbA1C \>9.0%)
* Unstable angina
* Recent myocardial infarction, cardiac surgery, or vascular surgery (\<3 months)
* Heart failure
* Peripheral artery disease (based on report of symptomatic claudication or ankle brachial index testing)
* Anemia (tHb \<10 mg/dL)
* Hepatic or renal disease
* Severe arthritis or mobility impairment that would interfere with exercise testing
* Current tobacco or marijuana use or nicotine use within the last year
* Dementia or evidence of cognitive impairment (Mini-Cog score \< 3)
* Engaging in \>150 minutes/week of moderate to vigorous physical activity (assessed via Low-Level Physical Activity Recall questionnaire)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT04262128
Study Brief:
Protocol Section:
NCT04262128