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Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)

CompletedNA

Sponsor: Cook County Health

Conditions: Diabetic Nephropathy

Interventions: Multifactorial Intervention

Countries: United States

The purpose of this study is to compare the progression of kidney disease in subjects with Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a general care and in subjects treated by multi-factorial intervention in the Diabetes-Renal Clinic.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. The participant is male or female diagnosed with Type 2 Diabetes mellitus defined by the American Diabetes Association criteria and must be aged 18 to 70 years.
2. The participant must have documented Advanced Diabetic Nephropathy (ADN) defined as presence of proteinuria or micro/macro-albuminuria and impaired GFR (by MDRD equation) corresponding to Chronic Kidney Disease (CKD) stages 3-4 (moderate-severe i.e. estimated GFR \>15ml/min and \<60ml/min).

A. Presence of macroalbuminuria B. Presence of microalbuminuria if no therapy with ACE inhibitors or ARBs C. Presence of current microalbuminuria and previous documentation of macroalbuminuria D. Presence of current microalbuminuria and previous documentation of Diabetic Retinopathy or laser therapy E. If only microalbuminuria and no A, B, C or D US of kidney shows NL size.
3. Minimal cognitive function for a diabetes self management
4. Fasting or random Blood glucose \<400mg/DL

Exclusion Criteria:

1. Patients with Type 1 Diabetes Mellitus.
2. Serum Creatinine \> 4.0 mg/dl and/or an estimated GFR of \< 15 ml/min.
3. Patients on renal replacement therapy.
4. Patients with Hyperkalemia (K\>5.0 meq/L).
5. Patients with known Renal Artery stenosis.
6. Patients with known cancer, hepatic impairment, dementia or other chronic medical diseases.
7. Patients with severe heart failure (NYHA Class III or IV symptoms and/or LVEF \<25%).
8. Patients with valvular or outflow tract obstruction.
9. Patients with significant disability that precludes regular attendance at clinics for follow-up.
10. Patients unwilling or unable to provide informed consent.
11. Pregnant or lactating women.
12. Current addiction to substance or alcohol abuse.

Locations (1)

Chicago, Illinois, United States