Purpose

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.

Condition

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Normal Glucose Tolerance (NGT)
Individuals with normal glucose tolerance - dapagliflozin vs placebo
  • Drug: Dapagliflozin
    dapagliflozin, 10mg tablet
    Other names:
    • Farxiga
  • Drug: Placebo
    Placebo for dapagliflozin
Active Comparator
T2DM individuals
Individuals with type 2 diabetes mellitus - dapagliflozin vs placebo
  • Drug: Dapagliflozin
    dapagliflozin, 10mg tablet
    Other names:
    • Farxiga
  • Drug: Placebo
    Placebo for dapagliflozin

Recruiting Locations

University of Texas Health Science Center
San Antonio, Texas 78229
Contact:
Eugenio Cersosimo, MD
210-358-7200
cersosimo@uthscsa.edu

More Details

NCT ID
NCT02981966
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Eugenio Cersosimo, MD, PhD
210-358-7200
cersosimo@uthscsa.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.