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

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Osteoarthrosis

Treatments: Drug: Methylprednisolone; Drug: Isotonic Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02332603

HK_VL_08_2014c

Details and patient eligibility

About

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.

Full 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

Enrollment: 134 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No 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

Trial design

134 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

Preoperative single high dose of Solu-Medrol 125 mg iv.

Treatment:

Drug: Methylprednisolone

Isotonic Sodium Chloride

Placebo Comparator group

Description:

Preoperative single dose of isotonic Sodium Chloride

Treatment:

Drug: Isotonic Sodium Chloride