Not Yet RecruitingPhase 4ACTRN12620000745943

The role of SGLT-2 inhibitors (Empagliflozin) in treating steroid induced hyperglycaemia in the management of glucocorticoid induced hypoerglycaemia in adults with and without diabetes.

"The role of SGLT-2 inhibitors (Empagliflozin) in the management of glucocorticoid induced hyperglycaemia in adults with and without diabetes"


Sponsor

Endocrinology Department, Gosford Hospital

Enrollment

30 participants

Start Date

Oct 1, 2020

Study Type

Interventional

Conditions

Summary

Availability of an oral tablet, empagliflozin (EG) is seen as a potential alternative to insulin injections for elevated glucose levels due to steroid treatment. We aim to investigate this. EG is already widely used for treatment in diabetic patients.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria8

  • Informed consent
  • Adults aged 18 years old and older
  • Patients on Glucocorticoid therapy equivalent to 10mg prednisolone or more with planned duration of treatment for at
  • least 4 weeks
  • Patients without prior history of diabetes
  • Patients with pre-existing diabetes on single agent metformin therapy
  • blood glucose readings measuring more than 10mmol/L within a 24 hour period OR
  • random blood glucose reading measuring more than 15mmol/L

Exclusion Criteria13

  • Renal impairment eGFR less than 45ml/minute
  • Poor oral intake or patient on a low carbohydrate or ketogenic diet
  • Patient states that they are actively following a low carbohydrate diet which is
  • less than 130grams of carbohydrates a day
  • Patient states that they are actively following a ketogenic diet which is 20-50grams of carbohydrates a day
  • Patient with active malignancy
  • History of recurrent genitourinary infections
  • Need for ICU admission at the time of recruitment
  • Current use of SGLT-2 inhibitors
  • Acute CVA in the past 2/12
  • Pregnancy/ Breast feeding
  • Volume depletion at the time of recruitment (gastroenteritis, acute kidney injury, fluid restriction of 1.5litres/day)
  • Inability to consent

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Interventions

Pilot study. Participants: Adults who meet the trial inclusion criteria. Participants will be prescribed 10mg tablet of empagliflozin daily, taken orally, for a duration of 4weeks. Participants

Pilot study. Participants: Adults who meet the trial inclusion criteria. Participants will be prescribed 10mg tablet of empagliflozin daily, taken orally, for a duration of 4weeks. Participants will have blood and urine test at the start including Hba1c/ full blood count, serum urea and electrolytes and urine albumin excretion. At the end of the trial similar blood and urine tests will be done. Participants will email their blood glucose levels every week to the investigators until completion of the trial. Participants will be seen in clinic at the end of the study period and sooner if there are any clinical issues related to treatment. If participants are not able to complete the study period, any excess medications are returned to the investigators for appropriate disposal


Locations(2)

Gosford Hospital - Gosford

NSW,QLD, Australia

Gold Coast University Hospital - Southport

NSW,QLD, Australia

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ACTRN12620000745943