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Metabolic Syndrome and Degenerate Meniscus Tears

Primary Purpose

Metabolic Syndrome, Meniscus; Degeneration

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
The First People's Hospital of Jingzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, degenerate meniscus lesions, Calorie restricted diet, exercise, arthroscopic partial meniscectomy

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be age between 35 and 70 years old;
  • Clinical diagnosis of metabolic syndrome;
  • 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;

Sites / Locations

  • First Affiliated Hospital of Jinzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Calorie restricted diet and excecise intervention

libitum diet and waiting list control group

Early APM group

delayed APM group recruit participants with symptoms lasting for more than 6 months

Arm Description

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.

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 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

Outcomes

Primary Outcome Measures

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)
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.
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.
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.
height
height in meters
weight
weight in kilograms
BMI
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2
waist circumstance
waist circumstance in centimeter
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.
systolic blood pressure
systolic blood pressure in mm Hg
diastolic blood pressure
diastolic blood pressure in mm Hg
triglyceride
triglyceride in mmol/L
HDL-C
high-density lipoprotein cholesterol in mmol/L
LDL-C
low-density lipoprotein cholesterol in mmol/L
fast blood glucose
fast blood glucose in mmol/L
total Cholesterol
total Cholesterol in mmol/L
β-2 microglobulin
β-2 microglobulin in mg/L
diabetes history
diabetes history
cardio vascular disease history
cardio vascular disease history
hypertension history
hypertension history
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2021
Last Updated
April 7, 2021
Sponsor
The First People's Hospital of Jingzhou
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1. Study Identification

Unique Protocol Identification Number
NCT04837456
Brief Title
Metabolic Syndrome and Degenerate Meniscus Tears
Official Title
First Affilated Hospital of Jinzhou Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Jingzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Meniscus; Degeneration
Keywords
Metabolic Syndrome, degenerate meniscus lesions, Calorie restricted diet, exercise, arthroscopic partial meniscectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calorie restricted diet and excecise intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
libitum diet and waiting list control group
Arm Type
Experimental
Arm Description
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.
Arm Title
Early APM group
Arm Type
Experimental
Arm Description
Early APM group participants received APM with syndrome within 3 to 6 months
Arm Title
delayed APM group recruit participants with symptoms lasting for more than 6 months
Arm Type
Experimental
Arm Description
delayed APM group recruit participants with symptoms lasting for more than 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Calorie restricted diet and exercise intervention
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
libitum diet and waiting list control group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Early arthroscopic partial menisectomy group
Intervention Description
Early APM group participants received APM with syndrome within 3 to 6 months
Intervention Type
Procedure
Intervention Name(s)
delayed APM group recruit participants with symptoms lasting for more than 6 months
Intervention Description
delayed APM group recruit participants with symptoms lasting for more than 6 months
Primary Outcome Measure Information:
Title
Knee KOOS4
Description
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)
Time Frame
up to 12 months
Title
the scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
up to 12 months
Title
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC).
Description
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.
Time Frame
up to 12 months
Title
The WOMET score
Description
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.
Time Frame
up to 12 months
Title
height
Description
height in meters
Time Frame
up to 12 months
Title
weight
Description
weight in kilograms
Time Frame
up to 12 months
Title
BMI
Description
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2
Time Frame
up to 12 months
Title
waist circumstance
Description
waist circumstance in centimeter
Time Frame
up to 12 months
Title
Kellgren-Lawrence grade
Description
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.
Time Frame
up to 12 months
Title
systolic blood pressure
Description
systolic blood pressure in mm Hg
Time Frame
up to 12 months
Title
diastolic blood pressure
Description
diastolic blood pressure in mm Hg
Time Frame
up to 12 months
Title
triglyceride
Description
triglyceride in mmol/L
Time Frame
up to 12 months
Title
HDL-C
Description
high-density lipoprotein cholesterol in mmol/L
Time Frame
up to 12 months
Title
LDL-C
Description
low-density lipoprotein cholesterol in mmol/L
Time Frame
up to 12 months
Title
fast blood glucose
Description
fast blood glucose in mmol/L
Time Frame
up to 12 months
Title
total Cholesterol
Description
total Cholesterol in mmol/L
Time Frame
up to 12 months
Title
β-2 microglobulin
Description
β-2 microglobulin in mg/L
Time Frame
up to 12 months
Title
diabetes history
Description
diabetes history
Time Frame
up to 12 months
Title
cardio vascular disease history
Description
cardio vascular disease history
Time Frame
up to 12 months
Title
hypertension history
Description
hypertension history
Time Frame
up to 12 months
Title
Lysholm knee score
Description
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.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be age between 35 and 70 years old; Clinical diagnosis of metabolic syndrome; 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyu Wang, Doctor
Organizational Affiliation
The First People's Hospital of Jingzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Metabolic Syndrome and Degenerate Meniscus Tears

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