Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    48
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 25 January 2021
electrocardiogram
metformin
sglt2 inhibitor
dapagliflozin
sulfonylurea
sglt2

Summary

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.

Description

Researchers will measure the rate of hepatic and renal glucose production following dapagliflozin administration to determine the site of increase in EGP, liver versus kidney. Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals. Because the increase in EGP is associated with an increase in plasma glucagon concentration and renal glucose production is stated to be unresponsive to glucagon, the investigators anticipate that the liver will be responsible, in part, for the increase in EGP.

Details
Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Placebo, Dapagliflozin
Clinical Study IdentifierNCT02981966
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 or NIDDM?
Do you have any of these conditions: type 2 diabetes or diabetes type 2 or Diabetes Mellitus Type 2 or type ii diabetes or noninsulin-dependent diabetes mellitus or NIDDM or type 2 diabet...?
-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
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