Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty

Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02332603

Enrollment

134

Registered

2015-01-07

Start date

2015-01-31

Completion date

2017-01-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthrosis

Keywords

Glucocorticoid, Glucose homeostasis, Knee arthroplasty, total, Hip arthroplasty, total

Brief summary

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.

Detailed description

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

Interventions

DRUGMethylprednisolone

Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride

DRUGIsotonic Sodium Chloride

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Osteoarthrosis * Undergoing total unilateral hip- or knee arthroplasty surgery * Speak and understand Danish * Have given informed consent

Exclusion criteria

* Revision or bilateral hip- or knee-arthroplasty surgery * General anaesthesia * Allergy or intolerance towards Methylprednisolone * Local or systemic infection * Permanent systemic treatment with steroids within 30 days preoperatively * Insulin-dependent diabetes * Active treatment of ulcer within 3 months preoperatively * Cancer disease * Autoimmune disease incl. rheumatoid arthritis * Pregnant or breast feeding women * Menopause \<1 year

Design outcomes

Primary

Measure	Time frame
Changes in plasma blood glucose from baseline (before surgery) to 48 hours after surgery	baseline to 48 hours

Secondary

Measure	Time frame
Changes in plasma C-peptide from baseline (before surgery) to 48 hours after surgery	baseline to 48 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026