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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02415556
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 50-85 years old
* Able to walk for 6 minutes
* Diabetes type 2 (DM) group: diagnosis and treatment for type 2 DM with non-insulin oral or injectable agents
* Non-DM group with similar age range as the DM group, non-diabetic fasting plasma glucose (\<126 mg/dL) and hemoglobin A1c (HbA1c) (\<6.5%)
* Participants capable of providing informed consent
Exclusion Criteria:
* Type 2 DM treated with insulin (since 9/25/2017)
* Type 1 DM
* Intolerance to insulin
* History of severe hypoglycemia
* Participants who have \>1 asymptomatic and/or symptomatic episode of hypoglycemia (glucose \< 54 mg/dL) during finger stick or plasma glucose (cut off value since 6/11/2018)
* Acute medical condition that required either hospitalization or surgery within the past 6 months (e.g., severe hypoglycemia, malignancies, myocardial infarction,stroke)
* Liver or renal failure or transplant
* Dementia (Mini Mental State Examination \[MMSE\] scores ≤20)
* Current recreational drug or alcohol abuse
* Serious systemic disease that would interfere with conduction of clinical trial (mild forms of neurological conditions e.g. Parkinson's Disease, autonomic neuropathy etc. would be allowed)
* Magnetic Resonance Imaging (MRI) substudy in 40 DM patients only: claustrophobia and implants incompatible with 3-Tesla MRI
* Safety substudy in 20 IDDM patients only: Insulin-treated type 2 diabetics with a C-peptide of \<0.8 ng/mLd and fasting blood glucose \>150 mg/dL will be excluded even without history of hypoglycemia during finger stick measurements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT02415556
Study Brief:
Protocol Section:
NCT02415556