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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Tampere
Tampere University Hospital
Information provided by (Responsible Party):
Esa Jamsen, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier:
NCT01743313
First received: December 2, 2012
Last updated: April 18, 2014
Last verified: April 2014
  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.


Condition
Hyperglycemia
Hypercholesterolemia
Prolonged 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 12-24 months after surgery ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma samples (one per patient).


Enrollment: 155
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 2, 2012
Last Updated: April 18, 2014
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 27, 2014