PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT03168295
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Sep 2020
Primary completion
Oct 31, 2018
Completion
May 15, 2019

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Placebo first and then dapagliflozin
    Renal transplant subjects with intact native kidneys with Type 2 Diabetes Mellitus receive dapagliflozin then placebo
  • Active Comparator: Dapagliflozin first then placebo
    Renal transplant subjects with intact native kidneys who are non-diabetic receive placebo then dapagliflozin
  • Other: Control Group
    Subjects who are type 2 diabetes mellitus who have not undergone renal transplant.

Primary Outcome Measure

Change in Endogenous Glucose Production (EGP) [ Time Frame: baseline and 240-300 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
The University of Texas Health Science Center at San Antonio· San Antonio, TX

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