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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT04442451
Eligibility Criteria:
Inclusion Criteria:
* Men and women adults 30 years to 85 years or less
* Pre-diabetes \[glycosylated hemoglobin (HbA1c) of 5.7-6.4% and fasting plasma glucose 100-125 mg/dL at the time of initial screening\]
* Controls \[normoglycemic with a HbA1c level ≤5.6% and fasting blood glucose ≤ 99 mg/dL (5.5 mmol/L)\]
* Type 2 Diabetes Mellitus \[elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%\]
Exclusion Criteria:
* Signs or symptoms of neuropathy
* Medications associated with advanced stages of T2D including insulin
* Poor glycemic control (HbA1c\>10%)
* Peripheral edema
* Severe obesity (BMI, \>45kg·m-2)
* Untreated hypothyroidism
* Smoking
* Hypertension
* Cardiovascular or musculoskeletal disease that preclude exercise testing
* Hormone replacement drugs or vasoactive medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT04442451
Study Brief:
Protocol Section:
NCT04442451