Find-A-Study

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration

Lay Description

The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated group will serve as controls for improved glycemic control, since the investigators have shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM patients.

Eligibility

Eligible Ages: Between 30 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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

Study Design

Arm Groups

Study Contact

Alberto Chavez-Velazquez

alberto.chavez-velazquez@uhs-sa.com

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Principal Investigator
Alberto Chavez-Velazquez