Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement

Hypercholesterolemia Clinical Trial

— HyTe-2  

Official title:

Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01743313
• Other study ID #: HyTe-2
• Status: Terminated
• Start date: April 2012
• Est. completion date: June 2017

Study information

• Verified date: October 2023
• Source: Coxa, Hospital for Joint Replacement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome.

Description:

Glucose metabolism disorders (diabetes and pre-diabetes) and metabolic syndrome are common in joint replacement recipients. Improved physical activity following joint replacement could lead to better glucose control in diabetes and ameliorate impaired glucose and cholesterol levels. In this study patients previously recruited to "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study are being followed-up for one year in order to analyze if joint replacements have an effect on these metabolic abnormalities. In addition, the effect of glucose metabolism disorders on occurrence of persistent pain after surgery is analyzed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: June 2017
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Primary hip and knee replacement for osteoarthritis

• Enrolled previously into study NCT01021826

Exclusion Criteria:

• Arthritis other than osteoarthritis (based on study NCT01021826)

• Medication affecting glucose metabolism (excl. antidiabetic agents) (based on study NTC01021826)

• Died before follow-up phase

• Did not undergo the planned hip or knee replacement

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hip Replacement
• Hypercholesterolemia
• Hyperglycemia
• Knee Replacement
• Metabolic Diseases
• Metabolic Syndrome
• Persistent Postoperative Pain

Locations

Country	Name	City	State
Finland	Coxa, Hospital for Joint Replacement	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Coxa, Hospital for Joint Replacement	Tampere University, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Rajamaki TJ, Jamsen E, Puolakka PA, Nevalainen PI, Moilanen T. Diabetes is associated with persistent pain after hip and knee replacement. Acta Orthop. 2015;86(5):586-93. doi: 10.3109/17453674.2015.1044389. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma adipokine and cytokine concentrations		Baseline and 12-24 months after surgery.
Primary	Change in glucose tolerance, measured using oral glucose tolerance test	The patients are grouped into three groups that are evaluated 12, 18 and ca. 24 months after surgery.	Baseline and 12-24 months after surgery
Secondary	Change in cholesterol levels (HDL, LDL, triglycerides)		Baseline and 12-24 months after surgery
Secondary	Prolonged postoperative pain	Assessed using visual analog scale. Patients are divided in three groups that are evaluated 12, 18 and 24 months after surgery.	12-24 months after surgery