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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT02911792
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, drug naïve, hyperfiltering and normofiltration patients with type 2 diabetes mellitus (T2DM)
* Hyperfiltration is defined by GFR \>135 ml/min•1.73m2
* Normofiltration by a GFR = 90-134 ml/min•1.73m2
* BMI = 20-45 kg/m2
* HbA1c = 7.5% to 12%
* Willingness to participate in the 16 week study protocol
* Hematocrit \>34% --BP \< 145/90 mmHg
Exclusion Criteria:
* \> 300 mg/day albumin excretion
* Ingestion of medications known to interfere with the renin-angiotensin system or renal function, including diuretic therapy
* Hospitalization for unstable angina, history of recent macrovascular (MI/stroke/TIA/ACS) disease, coronary artery revascularization (within 2 months prior to enrollment)
* Proliferative diabetic retinopathy
* History of cancer or major organ system disease
* New York Heart class II-IV heart failure Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3x ULN or total bilirubin \> 2.0 mg/dL (34.2 µmo/L)
* Treatment with steroids, beta blockers, alpha blockers, antiobesity drugs
* Pregnant or nursing mothers
* Premenopausal females who are not practicing acceptable contraceptive methods Participation in another trial with an investigational drug within 30 days Alcohol or drug abuse within the preceding 6 months
* Any condition, psychiatric or medical, which in the opinion of the investigator would interfere with the successful completion of the study
* Orthostatic hypotension (\> 15/10 mmHg decrease upon standing for 3 minutes)
* Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen, Hepatitis C virus antibody and HIV
* Volume depleted patients
* Estimated glomerular filtration rate \<60 mL/min•1.73m2. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT02911792
Study Brief:
Protocol Section:
NCT02911792