Metabolic SyndromeNCT04837456
Metabolic Syndrome and Degenerate Meniscus Tears
A study testing Calorie restricted diet and exercise intervention, Early arthroscopic partial menisectomy group and delayed APM group recruit participants with symptoms lasting for more than 6 months in people with Metabolic Syndrome and Meniscus; Degeneration, run by The First People's Hospital of Jingzhou at 1 site in China.
Trial summary
The aim is to determine the outcomes of calorie-restricted diet and exercise intervention; libitum diet and waiting list control; early arthroscopic partial meniscectomy(APM) or delayed APM effect on MetS patients with Degenerate menisucus lesions. 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; Degeneration
- What is being tested?
- Calorie restricted diet and exercise intervention, Early arthroscopic partial menisectomy group and delayed APM group recruit participants with symptoms lasting for more than 6 months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- Must be age between 35 and 70 years old;
- Clinical diagnosis of metabolic syndrome;
- 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 Affilated Hospital of Jinzhou Medical University
The aim is to determine the outcomes of calorie-restricted diet and exercise intervention; libitum diet and waiting list control; early arthroscopic partial meniscectomy(APM) or delayed APM effect on MetS patients with Degenerate menisucus lesions.
Read the detailed description
The investigators recruited 180 patients with Metabolic Syndrome and knee symptoms with degenerate meniscus lesions by MRI from orthopaedics department from June 2017 to March 2020 at First Affiliated Hospital of Jinzhou Medical University. Participants were diagnosed with MetS and degenerate meniscus tear with a mild or no osteoarthritis KL<2 verified by X ray. Participants were randomly dividied into calorie-restricted diet and exercise intervention group; libitum diet and waiting list control group; early APM (syndrome within 3-6 months) group or a delayed APM(syndrome more than 6 months) group as a computer sequenced number. The primary outcome was the change in metabolic syndrome components and knee function score of WOMAC, KOOS,WOMET,IKDC were determined by two fixed orthopadic surgeons who were blinded to the intervention.
- Conditions
- Metabolic Syndrome, Meniscus; Degeneration
- Being tested
- Calorie restricted diet and exercise intervention, libitum diet and waiting list control group, Early arthroscopic partial menisectomy group, delayed APM group recruit participants with symptoms lasting for more than 6 months
- Keywords
- Metabolic Syndrome, degenerate meniscus lesions, Calorie restricted diet, exercise, arthroscopic partial meniscectomy
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restricted diet and exercise interventionDietary supplement
the calorie restricted diet were prescribed a balanced diet that provided an energy deficit of 800 kcal/day from their daily energy requirement.Macronutrient content of low caloric diet, expressed as percentage of ingested energy with carbohydrates 45-65%; fat 20-35%; and protein 10- 35%[36]. Participants were guided by a dietitian for adjustments of their caloric intake weekly for six months.Participants performed 1 or 2 sets at a resistance of approximately 65% of their one-repetition maximum, with 8 to 12 repetitions of each exercise; they gradually increased the intensity to 2 to 3 sets at a resistance of approximately 80% of their one-repetition maximum, with 6 to 8 repetitions of each exercise.
libitum diet and waiting list control groupProcedure or surgery
libitum diet and waiting list control group, participants then underwent a calorie of 2000 calorie above based on libitum free diets recommended to adults and normal physical activity without exercise during the program.
Early arthroscopic partial menisectomy groupProcedure or surgery
Early APM group participants received APM with syndrome within 3 to 6 months
delayed APM group recruit participants with symptoms lasting for more than 6 monthsProcedure or surgery
delayed APM group recruit participants with symptoms lasting for more than 6 months
| Study group | Role | What they receive |
|---|---|---|
| Calorie restricted diet and excecise intervention | Experimental | a balanced diet that provided an energy deficit of 800 kcal/day from their daily energy requirement [36]. Macronutrient content of low caloric diet, expressed as percentage of ingested energy with carbohydrates 45-65%; fat 20-35%; and protein 10- 35%[36].Each session was approximately 150 minutes one week for six months and consisted of aerobic exercises, resistance training, and exercises to improve flexibility and balance. Receives: Dietary Supplement: Calorie restricted diet and exercise intervention |
| libitum diet and waiting list control group | Experimental | participants then underwent a calorie of 2000 calorie above based on libitum free diets recommended to adults and normal physical activity without exercise during the program. Receives: Procedure: libitum diet and waiting list control group |
| Early APM group | Experimental | Early APM group participants received APM with syndrome within 3 to 6 months Receives: Procedure: Early arthroscopic partial menisectomy group |
| delayed APM group recruit participants with symptoms lasting for more than 6 months | Experimental | delayed APM group recruit participants with symptoms lasting for more than 6 months Receives: Procedure: delayed APM group recruit participants with symptoms lasting for more than 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee KOOS4
the Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems) life (KOOs 4 ) were assessed.One of the most frequently-used knee-specific PROMs is the Knee injury and Osteoarthritis Outcome Score (KOOS) which was developed for adults who have knee OA or knee injuries.KOOS holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) 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 months
the scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
the WOMAC score is a disease-specific self-report multidimensional questionnare assesing pain, siffness, and physical functional disability.WOMAC scores range from 0 to 100, with higher scores indicating worse physical function.
Measured: up to 12 months
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC).
The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear. The questionnaire contains 18 items scored in 1 of 3 ways: 11-point Likert scale, 5-point Likert scale, or dichotomous yes or no. After the participant completes the questionnaire, the scores are summed, and the total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function.
Measured: up to 12 months
The WOMET score
The WOMET is a meniscus-specific health-related quality-of-life instrument, validated especially for patients with a degenerative meniscal tear.The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items ad-dressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possi- ble score, and 0 is the worst possible score.
Measured: up to 12 months
height
height in meters
Measured: up to 12 months
weight
weight in kilograms
Measured: up to 12 months
BMI
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2
Measured: up to 12 months
waist circumstance
waist circumstance in centimeter
Measured: up to 12 months
Kellgren-Lawrence grade
A Kellgren-Lawrence grade of 0 indicates no osteoarthritis, a grade of 1 with questionable osteophyte indicates possible osteoarthritis; a grade of 2 with definite osteophyte and no joint-space narrowing indicates mild osteoarthritis, a grade of 3 with ≤50% joint-space narrowing or a grade of 4 with>50% joint-space narrowing indicates severe osteoarthritis were excluded.
Measured: up to 12 months
systolic blood pressure
systolic blood pressure in mm Hg
Measured: up to 12 months
diastolic blood pressure
diastolic blood pressure in mm Hg
Measured: up to 12 months
triglyceride
triglyceride in mmol/L
Measured: up to 12 months
HDL-C
high-density lipoprotein cholesterol in mmol/L
Measured: up to 12 months
LDL-C
low-density lipoprotein cholesterol in mmol/L
Measured: up to 12 months
fast blood glucose
fast blood glucose in mmol/L
Measured: up to 12 months
total Cholesterol
total Cholesterol in mmol/L
Measured: up to 12 months
β-2 microglobulin
β-2 microglobulin in mg/L
Measured: up to 12 months
diabetes history
diabetes history
Measured: up to 12 months
cardio vascular disease history
cardio vascular disease history
Measured: up to 12 months
hypertension history
hypertension history
Measured: up to 12 months
Lysholm knee score
The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jun 2017
- Primary completion1 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 189 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
- NCT04837456
- Sponsor's protocol ID
- FirstJingzhou
- Status last verified
- Apr 2021
- First submitted
- 6 Mar 2021
- Last updated
- 8 Apr 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Affilated Hospital of Jinzhou Medical University
- ClinicalTrials.gov ID
- NCT04837456
- Acronym / sponsor ID
- FirstJingzhou
- Conditions
- Metabolic Syndrome, Meniscus; Degeneration
- Keywords
- Metabolic Syndrome, degenerate meniscus lesions, Calorie restricted diet, exercise, arthroscopic partial meniscectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- The First People's Hospital of JingzhouUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 8 Apr 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.
The aim is to determine the outcomes of calorie-restricted diet and exercise intervention; libitum diet and waiting list control; early arthroscopic partial meniscectomy(APM) or delayed APM effect on MetS patients with Degenerate menisucus lesions.
Detailed description
The investigators recruited 180 patients with Metabolic Syndrome and knee symptoms with degenerate meniscus lesions by MRI from orthopaedics department from June 2017 to March 2020 at First Affiliated Hospital of Jinzhou Medical University. Participants were diagnosed with MetS and degenerate meniscus tear with a mild or no osteoarthritis KL<2 verified by X ray. Participants were randomly dividied into calorie-restricted diet and exercise intervention group; libitum diet and waiting list control group; early APM (syndrome within 3-6 months) group or a delayed APM(syndrome more than 6 months) group as a computer sequenced number. The primary outcome was the change in metabolic syndrome components and knee function score of WOMAC, KOOS,WOMET,IKDC were determined by two fixed orthopadic surgeons who were blinded to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calorie restricted diet and excecise intervention | Experimental | Dietary Supplement: Calorie restricted diet and exercise interventiona balanced diet that provided an energy deficit of 800 kcal/day from their daily energy requirement [36]. Macronutrient content of low caloric diet, expressed as percentage of ingested energy with carbohydrates 45-65%; fat 20-35%; and protein 10- 35%[36].Each session was approximately 150 minutes one week for six months and consisted of aerobic exercises, resistance training, and exercises to improve flexibility and balance. |
| libitum diet and waiting list control group | Experimental | Procedure: libitum diet and waiting list control groupparticipants then underwent a calorie of 2000 calorie above based on libitum free diets recommended to adults and normal physical activity without exercise during the program. |
| Early APM group | Experimental | Procedure: Early arthroscopic partial menisectomy groupEarly APM group participants received APM with syndrome within 3 to 6 months |
| delayed APM group recruit participants with symptoms lasting for more than 6 months | Experimental | Procedure: delayed APM group recruit participants with symptoms lasting for more than 6 monthsdelayed APM group recruit participants with symptoms lasting for more than 6 months |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be age between 35 and 70 years old;
- Clinical diagnosis of metabolic syndrome;
- 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 |
|---|---|---|
| Calorie restricted diet and exercise interventionthe calorie restricted diet were prescribed a balanced diet that provided an energy deficit of 800 kcal/day from their daily energy requirement.Macronutrient content of low caloric diet, expressed as percentage of ingested energy with carbohydrates 45-65%; fat 20-35%; and protein 10- 35%[36]. Participants were guided by a dietitian for adjustments of their caloric intake weekly for six months.Participants performed 1 or 2 sets at a resistance of approximately 65% of their one-repetition maximum, with 8 to 12 repetitions of each exercise; they gradually increased the intensity to 2 to 3 sets at a resistance of approximately 80% of their one-repetition maximum, with 6 to 8 repetitions of each exercise. | Dietary supplement | Calorie restricted diet and excecise intervention |
| libitum diet and waiting list control grouplibitum diet and waiting list control group, participants then underwent a calorie of 2000 calorie above based on libitum free diets recommended to adults and normal physical activity without exercise during the program. | Procedure or surgery | libitum diet and waiting list control group |
| Early arthroscopic partial menisectomy groupEarly APM group participants received APM with syndrome within 3 to 6 months | Procedure or surgery | Early APM group |
| delayed APM group recruit participants with symptoms lasting for more than 6 monthsdelayed APM group recruit participants with symptoms lasting for more than 6 months | Procedure or surgery | delayed APM group recruit participants with symptoms lasting for more than 6 months |
Primary outcome
Knee KOOS4
Time frame: up to 12 months
the Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems) life (KOOs 4 ) were assessed.One of the most frequently-used knee-specific PROMs is the Knee injury and Osteoarthritis Outcome Score (KOOS) which was developed for adults who have knee OA or knee injuries.KOOS holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
the scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: up to 12 months
the WOMAC score is a disease-specific self-report multidimensional questionnare assesing pain, siffness, and physical functional disability.WOMAC scores range from 0 to 100, with higher scores indicating worse physical function.
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC).
Time frame: up to 12 months
The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear. The questionnaire contains 18 items scored in 1 of 3 ways: 11-point Likert scale, 5-point Likert scale, or dichotomous yes or no. After the participant completes the questionnaire, the scores are summed, and the total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function.
The WOMET score
Time frame: up to 12 months
The WOMET is a meniscus-specific health-related quality-of-life instrument, validated especially for patients with a degenerative meniscal tear.The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items ad-dressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possi- ble score, and 0 is the worst possible score.
height
Time frame: up to 12 months
height in meters
weight
Time frame: up to 12 months
weight in kilograms
BMI
Time frame: up to 12 months
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2
waist circumstance
Time frame: up to 12 months
waist circumstance in centimeter
Kellgren-Lawrence grade
Time frame: up to 12 months
A Kellgren-Lawrence grade of 0 indicates no osteoarthritis, a grade of 1 with questionable osteophyte indicates possible osteoarthritis; a grade of 2 with definite osteophyte and no joint-space narrowing indicates mild osteoarthritis, a grade of 3 with ≤50% joint-space narrowing or a grade of 4 with>50% joint-space narrowing indicates severe osteoarthritis were excluded.
systolic blood pressure
Time frame: up to 12 months
systolic blood pressure in mm Hg
diastolic blood pressure
Time frame: up to 12 months
diastolic blood pressure in mm Hg
triglyceride
Time frame: up to 12 months
triglyceride in mmol/L
HDL-C
Time frame: up to 12 months
high-density lipoprotein cholesterol in mmol/L
LDL-C
Time frame: up to 12 months
low-density lipoprotein cholesterol in mmol/L
fast blood glucose
Time frame: up to 12 months
fast blood glucose in mmol/L
total Cholesterol
Time frame: up to 12 months
total Cholesterol in mmol/L
β-2 microglobulin
Time frame: up to 12 months
β-2 microglobulin in mg/L
diabetes history
Time frame: up to 12 months
diabetes history
cardio vascular disease history
Time frame: up to 12 months
cardio vascular disease history
hypertension history
Time frame: up to 12 months
hypertension history
Lysholm knee score
Time frame: up to 12 months
The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
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 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
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?
A study testing Calorie restricted diet and exercise intervention, Early arthroscopic partial menisectomy group and delayed APM group recruit participants with symptoms lasting for more than 6 months in people with Metabolic Syndrome and Meniscus; Degeneration, 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 3 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 8 Apr 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?
Knee KOOS4 (time frame: up to 12 months). The study lists 21 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 8 Apr 2021.