- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04921202
Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function
June 8, 2021 updated by: Hongyu Wang, The First People's Hospital of Jingzhou
First Affiliated Hospital of Jinzhou Medical Universtiy
Studies have suggested that Obese patients with metabolic syndrome(MetS)were correlated with knee joint degeneration and osteoarthritis.
However, no studies demonstrate the relationship between obese patients with metabolic syndrome and degenerate meniscus lesions and its knee function.The aim is to detect the correlation between obese patients with metabolic syndrome and degenerate meniscus injuries.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Obese patients with metabolic syndrome(MetS)were correlated with knee joint degeneration and osteoarthritis.
However, no studies demonstrate the relationship between patients with metabolic syndrome and degenerate meniscus lesions or knee function.
Participants were recruited from First Affiliated Hospital of Jinzhou Medical University.
100 BMI<24 people without Metabolic syndrome volunteers aged between 35-70 years old and 80 Metabolic syndrome patients with BMI>27 were included in the study.
Obese patients with MetS were assessed knee function and degenerate meniscus tears verified by magnetic resonance imaging.
And patients with a mild or no osteoarthritis with Kellgren and Lawrence grade<2 verified by X ray.
We tested the relationship between metabolic syndrome and degenerate meniscus lesions.
Obese patients with MetS and volunteers were detected by Mcmurry's test and MRI image to measure degeneration grade of meniscus tears.
Number of MetS components were accounted and the knee function KOOS, IKDC score or degenerate meniscus tears were analyzed.
Study Type
Observational
Enrollment (Actual)
180
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
-
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Liaoning
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Jinzhou, Liaoning, China, 121000
- First Affiliated Hospital of Jinzhou Medical University
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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
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
participants from Jinzhou City, west of Liaoning Province
Description
Inclusion Criteria:
- Must be age between 35 and 70 years old;
- Clinical diagnosis of metabolic syndrome;
- BMI score more than 27 or less than 24
- Clinical diagnosis of 3 grade degneration meniscus leisons;
Exclusion Criteria:
- Must be able to have no acute knee injury such as car crash or acute sports injury;
- Must be able to have no knee surgeries history;
- Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
- Must be able to have no contraindications to MRI;
- Must be able to have no severe cardiopulmonary disease;
- Must be able to have no musculoskeletal or neuromuscular impairments ;
- Must be able to have good visual, hearing, or cognitive;
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 |
Intervention / Treatment |
---|---|
without metabolic syndrome and BMI<24
100 volunteers aged between 35-70 years old with body mass index(BMI)<24 without Metabolic syndrome
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Metabolic Syndrome with BMI>27
80 Metabolic syndrome patients with BMI>27 were included in the study
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Metabolic syndrome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Knee injury and Osteoarthritis Outcome Score (KOOS) total
Time Frame: up to 12 month
|
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items).
Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems).
|
up to 12 month
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The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score
Time Frame: up to 12 month
|
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score to determine the meniscus function.
The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear[36, 37] [38].
The questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.)
The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
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up to 12 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KOOS Pain subscale
Time Frame: up to 12 month
|
Pain including 9 items,The minimum value is 0 and maximum values subscale is 100, the scored separately from zero (extreme knee problems) to 100 (no knee problems)
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up to 12 month
|
Symptoms subscale
Time Frame: up to 12 month
|
Symptoms including 7 items,The minimum value is 0 and maximum values subscale is 100.
Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
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up to 12 month
|
Activities of Daily Living subscale
Time Frame: up to 12 month
|
Activities of Daily Living including 17 items,The minimum value is 0 and maximum values subscale is100.
Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems).
|
up to 12 month
|
Sport and Recreation function subscale
Time Frame: up to 12 month
|
Sport and Recreation function including 5 items,The minimum value is 0 and maximum values subscale is 100.
Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems).
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up to 12 month
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knee-related Quality of Life subscale
Time Frame: up to 12 month
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knee-related Quality of Life including 4 items,The minimum value is 0 and maximum values subscale is 100.
Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems).
|
up to 12 month
|
KOOS4
Time Frame: up to 12 month
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KOOS4, The minimum value is 0 and maximum values subscale is100.
KOOS4 defined as the average score for four of the five knee injury and osteoarthritis outcome score (KOOS) validity for patients with meniscal tears and osteoarthritis.
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up to 12 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 1, 2017
Primary Completion (Actual)
March 25, 2020
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
June 3, 2021
First Submitted That Met QC Criteria
June 8, 2021
First Posted (Actual)
June 10, 2021
Study Record Updates
Last Update Posted (Actual)
June 10, 2021
Last Update Submitted That Met QC Criteria
June 8, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jinzhou Medical University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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