Diabetes Mellitus, Type 2 Clinical Trial
Official title:
SGLT2 INHIBITION AND STIMULATIION OF ENDOGENOUS GLUCOSE PRODUCTION Significance - PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria.
Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose
concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal
denervation) or in subjects after renal sympathectomy (63) can add insight about the possible
role of a neural arc which mediates the changes in plasma glucagon and/or insulin
concentration in response to glucosuria.
Research Design/Plan: After screening, eligible subjects will receive 2 measurements of
endogenous glucose production with a prime-continuous infusion of 3-3H-glucose. Each
measurement will be performed on a separate day in random order after a 10-12 hour overnight
fast and will last 8 hours (from 6 AM to 2 PM). After a 3-hour tracer equilibration period,
each subject will receive one of the following medications in random order: (i) placebo and
(ii) dapagliflozin 10 mg. Following the test medication at 9 AM, blood samples will be drawn
every 20 minutes for an additional 5 hours and plasma glucose, insulin, C-peptide, glucagon,
catecholamine concentrations and tritiated glucose sp act will be measured.
Methods: Visit 1: Screening Visit 2: Endogenous Glucose Production Measurement (EGP) Visit 3:
After completing the first EGP measurement, subjects will return to the Diabetes Research
Unit for the second study.
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