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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

NCT02981966

Diabetes Mellitus, Type 2

COMPLETED PHASE4

Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria

NCT03331289

Diabetes Mellitus, Type 2

COMPLETED PHASE4

Empagliflozin and Renal Oxygenation in Healthy Volunteers

NCT03093103

Nephropathy

COMPLETED PHASE2

SGLT2 Inhibitors Prophylaxis Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease?

NCT04853615

SGLT2i Kideny Protection Against Contrast in Diabetic Kidney

UNKNOWN

The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease

NCT06528405

Acute Kidney Injury

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Post renal transplant type 2 diabetes mellitus patients and non-diabetic mellitus patients after renal transplant with a control group of type 2 diabetes mellitus who have not undergone renal transplant

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo first and then dapagliflozin

Renal transplant subjects with intact native kidneys with Type 2 Diabetes Mellitus receive dapagliflozin then placebo

Group Type EXPERIMENTAL

Dapagliflozin 10mg then Placebo Oral Tablet

Intervention Type DRUG

SGLT2 inhibitor - Dapagliflozin then Placebo

Placebo Oral Tablet then Dapagliflozin 10mg

Intervention Type DRUG

Placebo then SGLT2 inhibitor - Dapagliflozin

Dapagliflozin first then placebo

Renal transplant subjects with intact native kidneys who are non-diabetic receive placebo then dapagliflozin

Group Type ACTIVE_COMPARATOR

Dapagliflozin 10mg then Placebo Oral Tablet

Intervention Type DRUG

SGLT2 inhibitor - Dapagliflozin then Placebo

Placebo Oral Tablet then Dapagliflozin 10mg

Intervention Type DRUG

Placebo then SGLT2 inhibitor - Dapagliflozin

Control Group

Subjects who are type 2 diabetes mellitus who have not undergone renal transplant.

Group Type OTHER

Dapagliflozin 10mg then Placebo Oral Tablet

Intervention Type DRUG

SGLT2 inhibitor - Dapagliflozin then Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin 10mg then Placebo Oral Tablet

SGLT2 inhibitor - Dapagliflozin then Placebo

Intervention Type DRUG

Placebo Oral Tablet then Dapagliflozin 10mg

Placebo then SGLT2 inhibitor - Dapagliflozin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Farxiga then placebo Placebo then Farxiga

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age = 18-70 years
* BMI = 18.5-40 kg/m2
* HbA1c ≥ 7.0% and ≤10.0% for type 2 diabetics
* males or females
* Must be at least 3 months post renal transplantation and be on a stable dose of prednisone (≤5 mg/day), tacrolimus, and mycophenolate mofetil
* Not taking any antidiabetic medications or who are treated with metformin, sulfonylurea, dipeptidyl peptidase 4 (DPP4) inhibitor, thiazolidinedione or some combination
* Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis

Exclusion Criteria

* Subjects who are taking insulin or SGLT2 inhibitor are excluded
* Only subjects whose body weight has not been stable (± 3 lbs) over the preceding three months and/or who participate in an excessively heavy exercise program will be excluded.
* Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \>1.4 females or \>1.5 males (and eGFR \<45ml/min.1.73m2), or 24-hour urine albumin excretion \> 300 mg will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No