Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT02332603
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2015-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: