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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
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Osteoarthrosis Drug: Methylprednisolone Drug: Isotonic Sodium Chloride Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
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


Arm Intervention/treatment
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Drug: Methylprednisolone
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
Placebo




Primary Outcome Measures :
  1. Changes in plasma blood glucose from baseline (before surgery) to 48 hours after surgery [ Time Frame: baseline to 48 hours ]

Secondary Outcome Measures :
  1. Changes in plasma C-peptide from baseline (before surgery) to 48 hours after surgery [ Time Frame: baseline to 48 hours ]


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Rigshospitalet, Denmark
Bispebjerg Hospital
Investigators
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Principal Investigator: Viktoria Lindberg-Larsen, MD Section for Surgical Pathophysiology, Rigshospitalet

Publications:

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Responsible Party: Viktoria Oline Lindberg-Larsen, MD, research assistant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02332603     History of Changes
Other Study ID Numbers: HK_VL_08_2014c
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark:
Glucocorticoid
Glucose homeostasis
Knee arthroplasty, total
Hip arthroplasty, total

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents