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

This study has suspended participant recruitment.
(Primary researcher not able to continue research at the moment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743313
First Posted: December 6, 2012
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Tampere
Tampere University Hospital
Information provided by (Responsible Party):
Esa Jamsen, Coxa, Hospital for Joint Replacement
  Purpose
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.

Condition
Hyperglycemia Hypercholesterolemia Persistent Postoperative Pain Hip Replacement Knee Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement

Resource links provided by NLM:


Further study details as provided by Esa Jamsen, Coxa, Hospital for Joint Replacement:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change in cholesterol levels (HDL, LDL, triglycerides) [ Time Frame: Baseline and 12-24 months after surgery ]
  • 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.


Other Outcome Measures:
  • Change in plasma adipokine and cytokine concentrations [ Time Frame: Baseline and 12-24 months after surgery. ]

Biospecimen Retention:   Samples Without DNA
Plasma samples (one per patient).

Enrollment: 155
Study Start Date: April 2012
Estimated Study Completion Date: June 2018
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tertiary care clinic
Criteria

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
  Contacts and Locations
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): NCT01743313


Locations
Finland
Coxa, Hospital for Joint Replacement
Tampere, Finland, 33520
Sponsors and Collaborators
Coxa, Hospital for Joint Replacement
University of Tampere
Tampere University Hospital
Investigators
Study Director: Esa Jämsen, MD, PhD Coxa, Hospital for Joint Replacement
  More Information

Publications:
Responsible Party: Esa Jamsen, MD, PhD, Researcher, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT01743313     History of Changes
Other Study ID Numbers: HyTe-2
First Submitted: December 2, 2012
First Posted: December 6, 2012
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Esa Jamsen, Coxa, Hospital for Joint Replacement:
glucose metabolism disorders
metabolic syndrome
joint replacement
osteoarthritis

Additional relevant MeSH terms:
Metabolic Syndrome X
Pain, Postoperative
Hypercholesterolemia
Hyperglycemia
Metabolic Diseases
Glucose Metabolism Disorders
Insulin Resistance
Hyperinsulinism
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders