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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT01743313
- Acronym / sponsor ID
- HyTe-2 / HyTe-2
- Conditions
- Hyperglycemia, Hypercholesterolemia, Persistent Postoperative Pain, Hip Replacement, Knee Replacement
- Keywords
- glucose metabolism disorders, metabolic syndrome, joint replacement, osteoarthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Primary researcher not able to continue research at the moment.
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Coxa, Hospital for Joint ReplacementUniversity, hospital or other
- Collaborators
- Tampere University, Tampere University Hospital
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic
Key inclusion criteria (2 listed)
- Primary hip and knee replacement for osteoarthritis
- Enrolled previously into study NCT01021826
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Change in cholesterol levels (HDL, LDL, triglycerides)
Time frame: Baseline and 12-24 months after surgery
Prolonged postoperative pain
Time frame: 12-24 months after surgery
Results and safety
The study was stopped early (reason given: Primary researcher not able to continue research at the moment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Results publication: PubMed 25953426Rajamaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esa Jämsen, MD, PhD study director
Coxa, Hospital for Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Hypercholesterolemia, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Primary researcher not able to continue research at the moment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance, measured using oral glucose tolerance test (time frame: Baseline and 12-24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.