HyperglycemiaHyTe-2NCT01743313
Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement
An observational study of Hyperglycemia and Hypercholesterolemia, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Hyperglycemia, Hypercholesterolemia, Persistent Postoperative Pain
- How many people
- 155 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2012to Jun 2017
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary care clinic
Who may be able to join
- Primary hip and knee replacement for osteoarthritis
- Enrolled previously into study NCT01021826
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperglycemia, Hypercholesterolemia, Persistent Postoperative Pain, Hip Replacement, Knee Replacement
- Keywords
- glucose metabolism disorders, metabolic syndrome, joint replacement, osteoarthritis
- Medical subject headings
- Hyperglycemia, Hypercholesterolemia, Glucose Metabolism Disorders, Metabolic Syndrome, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12-24 months after surgery
Secondary outcomes (2)
Change in cholesterol levels (HDL, LDL, triglycerides)
Measured: Baseline and 12-24 months after surgery
Prolonged postoperative pain
Assessed using visual analog scale. Patients are divided in three groups that are evaluated 12, 18 and 24 months after surgery.
Measured: 12-24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionJun 2017
Why it stopped: Primary researcher not able to continue research at the moment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coxa, Hospital for Joint Replacement
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Tampere University Hospital
- Responsible party
- Principal investigator, Esa Jamsen, Coxa, Hospital for Joint Replacement
- Investigators
- Esa Jämsen, MD, PhD, Study director, Coxa, Hospital for Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743313
- Sponsor's protocol ID
- HyTe-2
- Acronym
- HyTe-2
- Status last verified
- Oct 2023
- First submitted
- 2 Dec 2012
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25953426