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Lay Description

Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.

Category

  • Urinary Tract and Kidney
IRB Number
20160596HU
NCT Number
NCT02981966
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 25-35 kg/m^2
  • Normal Glucose Tolerance subjects (24)
  • Type 2 Diabetic Subjects (24)
  • Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
  • Diabetic subjects must have HbA1c <8.0%
  • Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.
  • Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

Exclusion Criteria

  • Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.
  • Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.

Study Design

Arm Groups

Study Contact


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

Principal Investigator
Eugenio Cersosimo