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 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT02804932
Eligibility Criteria:
For 50 patients with documented Type 2 diabetes
Inclusion Criteria:
* Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
* Age is \> or = 40 and \< or = 77 years of age
* Documented Type 2 diabetes
Exclusion Criteria:
* diagnosis of type 2 diabetes \< 3 years prior to enrollment
* HbA1c \<6.0% or \>10.0%
* body mass index \> 42 kg/m2
* incident cardiovascular events in the last year (heart attack, stroke)
* symptomatic coronary artery disease and/or heart failure
* uncontrolled hypertension
* hypotension (resting systolic BP \< 90 mmHg)
* renal impairment with creatinine clearance (eGFR) of \<50 ml/min
* smoking or history of smoking within past one year
* use of medication which contain nitrates
* use of anti-coagulant drugs
* use of anti-platelet drugs
* participation in research studies in which medications or interventions are given which would potentially alter subject responses in the current study
For 15 age- and weight-matched nondiabetic control subjects
Inclusion Criteria:
* Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
* Age is \> or = 40 and \< or = 77 years of age
Exclusion Criteria:
* Diagnosis of diabetes (Type 1 or Type 2)
* body mass index \> 42 kg/m2
* incident cardiovascular events in the last year (heart attack, stroke)
* symptomatic coronary artery disease and/or heart failure
* uncontrolled hypertension
* hypotension (resting systolic BP \< 90 mmHg)
* renal impairment with creatinine clearance (eGFR) of \<50 ml/min
* smoking or history of smoking within past one year
* use of medication which contain nitrates
* use of anti-coagulant drugs
* use of anti-platelet drugs
* participation in research studies in which medications or interventions are given which would potentially alter subject responses in the current study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
77 Years
Study:
NCT02804932
Study Brief:
Protocol Section:
NCT02804932