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Completed

NCT Number: NCT03713190

Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).

A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (ESRD)

Completed

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Key information

About this study

The impact of SGLT-2 inhibition on endogenous glucose production and plasma glucagon levels will be compared measured in patients with ESRD.The secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, FFA,GH, epinephrine, norepinephrine, cortisol and blood pressure during the last hour of the experiment between empagliflozin versus placebo administration in patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females
  • Age = 30-70 years
  • BMI< 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
  • Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c >5.7 % and <10.0%)
  • End Stage Renal Disease (GFR <15 ml/min/1.73 m 2 or hemodialysis)
  • Subjects are capable of giving informed consent

Exclusion criteria

  • Prednisone treatment
  • Beta blocker or any medication that affects sympathetic/parasympathetic activity
  • Known Empagliflozin Excipient Hypersensitivity
  • Liver function enzymes higher more than two times the upper limit
  • Ongoing urinary tract infection
  • history of cancer of any type;
  • cerebrovascular or symptomatic peripheral vascular disease;
  • heart disease class III or IV NYHA;
  • Type 1 Diabetes
  • drug or alcohol abuse;
  • life expectancy <3 yrs
  • blood pressure >150/100 mmHg
  • Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
  • Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment)
  • Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures

Treatment and study plan

Empagliflozin

Combination Product

Sodium-glucose co-transporter 2 (SGLT2), a low-affinity, high-capacity member of an increasingly numerous family of co-transporters, is highly expressed in the proximal renal tubule, and account for the majority of the reabsorption of filtered glucose.

Placebo

Drug

A substance without specific pharmacology principles

Primary outcomes

  1. Changes in plasma Glucose level

    Time frame: 2 hours

    Because of their mechanism of action, SGLT-2 inhibitor efficacy to reduce plasma glucose level is highly dependent upon renal function. With GFR decreasing, glucose tubular load will decrease and less glucose will be reabsorbed because of SGLT2-inhibition.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

A Phase II,Randomized,Cross-over,Double-blind, Placebo- Controlled,Single Center Study of the Effect of Empagliflozin a SGLT-2 Inhibitor,on Endogenous Glucose Production and Plasma Glucagon Levels in Patients With ESRD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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