Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
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|ClinicalTrials.gov Identifier: NCT02332603|
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : January 18, 2017
This study evaluates the pathophysiological effects of a single dose of Methylprednisolone administered prior to total hip- and knee-arthroplasty surgery. The investigators examine the effect on blood glucose homeostasis.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.
The investigators hypothesize that the glucose homeostasis remains equally stable in the group receiving Methylprednisolone as in the group receiving placebo.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthrosis||Drug: Methylprednisolone Drug: Isotonic Sodium Chloride||Phase 3|
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.
Glucocorticoid might change the glucose metabolism as it induces insulin-resistance. Glucocorticoids are known to reduce the insulin-mediated glucose uptake by reducing the muscle glycogen synthase activity.
The effect of a single high dose of glucocorticoid is poorly described in the literature, and therefore calls for further investigation.
This study is embedded in a primary study registrated as: NCT02319343
For further details please view the EudraCT registration:
EudraCT nr.: 2014-003395-23
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Other Name: Solu-Medrol
Placebo Comparator: Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Drug: Isotonic Sodium Chloride
- Changes in plasma blood glucose from baseline (before surgery) to 48 hours after surgery [ Time Frame: baseline to 48 hours ]
- Changes in plasma C-peptide from baseline (before surgery) to 48 hours after surgery [ Time Frame: baseline to 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332603
|Copenhagen NV, Denmark, 2400|
|Principal Investigator:||Viktoria Lindberg-Larsen, MD||Section for Surgical Pathophysiology, Rigshospitalet|