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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01829256
Eligibility Criteria:
Inclusion Criteria:
* age ≥18 and less than75 years
* regular use of the Duke University Health System (≥2 primary care visits in 3 prior yrs)
* diagnosis of type 2 diabetes
* have at least 2 serum creatinine values available in the 3 prior years, separated by at least 3 months;
* preserved kidney function (eGFR between 45-90 ml/min/1.73m2 on most recent creatinine)
* evidence of diabetic nephropathy
* uncontrolled HTN (1y mean clinic SBP≥140 and/or DBP≥90).
Exclusion Criteria:
* no access to telephone
* not proficient in English
* nursing home/long-term care facility resident or receiving home health care
* impaired hearing/ speech/ vision
* participating in another trial (pharmaceutical or behavioral)
* planning to leave the area in the next 3 years
* pancreatic insufficiency or diabetes secondary to pancreatitis
* alcohol abuse (\>14 alcoholic beverages/ wk)
* diagnosis of non-diabetic kidney disease
* active malignancy (other than non-melanomatous skin cancer)
* life-threatening disease with death probable within 4 years
* Secondary hypertension (renovascular disease, Cushing's syndrome, primary aldosteronism, pheochromocytoma, hypo-/hyperthyroidism, hyperparathyroidism, coarctation of the aorta)
* Pregnancy, Breastfeeding
* Long-term or chronic dialysis
* Dementia
* Renal Transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01829256
Study Brief:
Protocol Section:
NCT01829256