Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement (HyTe-2)

October 17, 2023 updated by: Esa Jamsen, Coxa, Hospital for Joint Replacement

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

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.

Study Overview

Status

Terminated

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33520
        • Coxa, Hospital for Joint Replacement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

tertiary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hip and knee replacement recipients
Hip and knee replacement recipients (with osteoarthritis) enrolled previously into "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study (NCT01021826).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose tolerance, measured using oral glucose tolerance test
Time Frame: Baseline and 12-24 months after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cholesterol levels (HDL, LDL, triglycerides)
Time Frame: Baseline and 12-24 months after surgery
Baseline and 12-24 months after surgery
Prolonged postoperative pain
Time Frame: 12-24 months after surgery
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

Other Outcome Measures

Outcome Measure
Time Frame
Change in plasma adipokine and cytokine concentrations
Time Frame: Baseline and 12-24 months after surgery.
Baseline and 12-24 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coxa, Hospital for Joint Replacement

Collaborators

Tampere University
Tampere University Hospital

Investigators

  • Study Director: Esa Jämsen, MD, PhD, Coxa, Hospital for Joint Replacement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 2, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimated)

December 6, 2012

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HyTe-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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