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:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT06596967
Eligibility Criteria:
Inclusion Criteria:
1. age 55 and older
2. Type 2 Diabetes (documented by chart review, presence of treatment for type 2 Diabetes, fasting plasma glucose equal or greater than 126 mg/dL or A1C equal or greater than 6.5%).
Exclusion Criteria:
(1) HbA1c \<6.5% or \>9.0%, (2) body mass index \> 40 kg/m2, (3) insulin-dependent Type 1 Diabetes Mellitus, (4) incident cardiovascular events in the last year (heart attack, stroke), (5) symptomatic coronary artery disease and/or heart failure, (6) uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>110 mmHg), (7) hypotension (resting systolic BP \< 90 mmHg), (8) use of walking aid other than a cane, (9) active cancer, (10) impaired thermal sensation in the legs, (11) unable to fit into water-circulating garments, (12) orthopedic complications that preclude completion of physical function tests, (13) contraindications or inability to undergo a DXA scan, including implants, devices, or other foreign material, and inability to attain correct position and/or remain motionless for the measurement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT06596967
Study Brief:
Protocol Section:
NCT06596967