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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.

Category

  • Diabetes
  • Urinary Tract and Kidney
IRB Number
20160262HU
NCT Number
NCT02911792
Open to Enrollment
Yes

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


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

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Principal Investigator
Eugenio Cersosimo