Metabolic SyndromeNCT04921202
Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function
An observational study of Metabolic Syndrome and Meniscus Lesion, run by The First People's Hospital of Jingzhou at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Meniscus Lesion, Obesity, Abdominal
- What is being tested?
- Metabolic syndrome and meniscus injuries
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Mar 2021
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants from Jinzhou City, west of Liaoning Province
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000
About this study
Official title: 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.
Read the 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.
- Being tested
- Metabolic syndrome and meniscus injuries
- Keywords
- Metabolic Syndrome, degenerate meniscus lesions, obesity, knee function
- Medical subject headings
- Metabolic Syndrome, Obesity, Abdominal, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic syndrome and meniscus injuriesOther
Metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| without metabolic syndrome and BMI<24 | 100 volunteers aged between 35-70 years old with body mass index(BMI)<24 without Metabolic syndrome | |
| Metabolic Syndrome with BMI>27 | 80 Metabolic syndrome patients with BMI>27 were included in the study Receives: Other: Metabolic syndrome and meniscus injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Knee injury and Osteoarthritis Outcome Score (KOOS) total
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).
Measured: up to 12 month
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score
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.
Measured: up to 12 month
Secondary outcomes (6)
KOOS Pain subscale
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)
Measured: up to 12 month
Symptoms subscale
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)
Measured: up to 12 month
Activities of Daily Living subscale
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).
Measured: up to 12 month
Sport and Recreation function subscale
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).
Measured: up to 12 month
knee-related Quality of Life subscale
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).
Measured: up to 12 month
KOOS4
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.
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2017
- Primary completion25 Mar 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Jingzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyu Wang, The First People's Hospital of Jingzhou
- Investigators
- Hongyu Wang, Doctor, Principal investigator, The First People's Hospital of Jingzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921202
- Sponsor's protocol ID
- Jinzhou Medical University
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Affiliated Hospital of Jinzhou Medical Universtiy
- ClinicalTrials.gov ID
- NCT04921202
- Acronym / sponsor ID
- Jinzhou Medical University
- Keywords
- Metabolic Syndrome, degenerate meniscus lesions, obesity, knee function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- The First People's Hospital of JingzhouUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without metabolic syndrome and BMI<24 | – | –100 volunteers aged between 35-70 years old with body mass index(BMI)<24 without Metabolic syndrome |
| Metabolic Syndrome with BMI>27 | – | Other: Metabolic syndrome and meniscus injuries80 Metabolic syndrome patients with BMI>27 were included in the study |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants from Jinzhou City, west of Liaoning Province
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic syndrome and meniscus injuriesMetabolic syndrome | Other | Metabolic Syndrome with BMI>27 |
Primary outcome
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).
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.
6 secondary outcomes
KOOS Pain subscale
Time frame: up to 12 month
Symptoms subscale
Time frame: up to 12 month
Activities of Daily Living subscale
Time frame: up to 12 month
Sport and Recreation function subscale
Time frame: up to 12 month
knee-related Quality of Life subscale
Time frame: up to 12 month
KOOS4
Time frame: up to 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Hongyu Wang, Doctor principal investigator
The First People's Hospital of Jingzhou
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 Metabolic Syndrome and Meniscus Lesion, run by The First People's Hospital of Jingzhou at 1 site in China.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jun 2021. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the Knee injury and Osteoarthritis Outcome Score (KOOS) total (time frame: up to 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2021.