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Carina Kirstine Klarskov - One of the best experts on this subject based on the ideXlab platform.

  • study rationale and design of the eanitiate study empagliflozin compared to nph insulin for Steroid Diabetes a randomized controlled multicenter trial of safety and efficacy of treatment with empagliflozin compared with nph insulin in patients with newly onset Diabetes following initiation of glucocorticoid treatment
    2020
    Co-Authors: Carina Kirstine Klarskov, Helga Schultz, Frederik Persson, Tomas Moller Christensen, Thomas Almdal, Ole Snorgaard, Katrine B Hansen, Ulrik Pedersenbjergaard, Peter Kristensen
    Abstract:

    BACKGROUND A well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced Diabetes mellitus (GIDM). Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced Diabetes. METHODS EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset Diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects. DISCUSSION This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits. TRIAL REGISTRATION www.clinicaltrialsregister.eu no.: 2018-002640-82. Prospectively registered November 20th. 2018. Date of first patient enrolled: June 4th. 2019. This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.

  • study rationale and design of the eanitiate study empagliflozin compared to nph insulin for Steroid Diabetes a randomized controlled multicenter trial of safety and efficacy of treatment with empagliflozin compared with nph insulin in patients with newly onset Diabetes following initiation of glucocorticoid treatment
    2020
    Co-Authors: Carina Kirstine Klarskov, Helga Schultz, Frederik Persson, Tomas Moller Christensen, Thomas Almdal, Ole Snorgaard, Katrine B Hansen, Ulrik Pedersenbjergaard, Peter Lommer Kristensen
    Abstract:

    A well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced Diabetes mellitus (GIDM). Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced Diabetes. EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset Diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects. This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits. www.clinicaltrialsregister.eu no.: 2018–002640-82. Prospectively registered November 20th. 2018. Date of first patient enrolled: June 4th. 2019. This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.

Stamata Pagoni - One of the best experts on this subject based on the ideXlab platform.

Peter Lommer Kristensen - One of the best experts on this subject based on the ideXlab platform.

  • study rationale and design of the eanitiate study empagliflozin compared to nph insulin for Steroid Diabetes a randomized controlled multicenter trial of safety and efficacy of treatment with empagliflozin compared with nph insulin in patients with newly onset Diabetes following initiation of glucocorticoid treatment
    2020
    Co-Authors: Carina Kirstine Klarskov, Helga Schultz, Frederik Persson, Tomas Moller Christensen, Thomas Almdal, Ole Snorgaard, Katrine B Hansen, Ulrik Pedersenbjergaard, Peter Lommer Kristensen
    Abstract:

    A well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced Diabetes mellitus (GIDM). Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced Diabetes. EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset Diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects. This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits. www.clinicaltrialsregister.eu no.: 2018–002640-82. Prospectively registered November 20th. 2018. Date of first patient enrolled: June 4th. 2019. This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.

Peter Kristensen - One of the best experts on this subject based on the ideXlab platform.

  • study rationale and design of the eanitiate study empagliflozin compared to nph insulin for Steroid Diabetes a randomized controlled multicenter trial of safety and efficacy of treatment with empagliflozin compared with nph insulin in patients with newly onset Diabetes following initiation of glucocorticoid treatment
    2020
    Co-Authors: Carina Kirstine Klarskov, Helga Schultz, Frederik Persson, Tomas Moller Christensen, Thomas Almdal, Ole Snorgaard, Katrine B Hansen, Ulrik Pedersenbjergaard, Peter Kristensen
    Abstract:

    BACKGROUND A well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced Diabetes mellitus (GIDM). Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced Diabetes. METHODS EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset Diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects. DISCUSSION This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits. TRIAL REGISTRATION www.clinicaltrialsregister.eu no.: 2018-002640-82. Prospectively registered November 20th. 2018. Date of first patient enrolled: June 4th. 2019. This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.

Yifan Zhang - One of the best experts on this subject based on the ideXlab platform.

  • the difference between Steroid Diabetes mellitus and type 2 Diabetes mellitus a whole body 18f fdg pet ct study
    2020
    Co-Authors: Qingqing Zhao, Jinxin Zhou, Yu Pan, Liying Zhu, Yang Liu, Yifan Zhang
    Abstract:

    Steroid Diabetes mellitus (SDM) is a metabolic syndrome caused by an increase in glucocorticoids, and its pathogenesis is unclear. 18F-FDG PET/CT can reflect the glucose metabolism of tissues and organs under living conditions. Here, PET/CT imaging of SDM and type 2 Diabetes mellitus (T2DM) rats was used to visualize changes in glucose metabolism in the main glucose metabolizing organs and investigate the pathogenesis of SDM. SDM and T2DM rat models were established. During this time, PET/CT imaging was used to measure the %ID/g value of skeletal muscle and liver to evaluate glucose uptake. The pancreatic, skeletal muscle and liver were analyzed by immunohistochemistry. SDM rats showed increased fasting blood glucose and insulin levels, hyperplasia of islet α and β cells, increased FDG uptake in skeletal muscle accompanied by an up-regulation of PI3Kp85α, IRS-1, and GLUT4, no significant changes in liver uptake, and that glycogen storage in the liver and skeletal muscle increased. T2DM rats showed atrophy of pancreatic islet β cells and decreased insulin levels, significantly reduced FDG uptake and glycogen storage in skeletal muscle and liver. The pathogenesis of SDM is different from that of T2DM. The increased glucose metabolism of skeletal muscle may be related to the increased compensatory secretion of insulin. Glucocorticoids promote the proliferation of islet α cells and cause an increase in gluconeogenesis in the liver, which may cause increased blood glucose.