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

NCT03168295 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-09-17

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Dapagliflozin 10mg then Placebo Oral Tablet

SGLT2 inhibitor - Dapagliflozin then Placebo

DRUG

Placebo Oral Tablet then Dapagliflozin 10mg

Placebo then SGLT2 inhibitor - Dapagliflozin

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Ralph A DeFronzo, MD · The University of Texas Health Science at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-10-31
Completion
2019-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168295 on ClinicalTrials.gov