Metabolic Syndrome and Degenerate Meniscus Tears

Sponsor

The First People's Hospital of Jingzhou (Other)

Overall Status

Completed

CT.gov ID

NCT04837456

Collaborator

(none)

189

Enrollment

Location

Arms

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Meniscus; Degeneration	Dietary Supplement: Calorie restricted diet and exercise intervention Procedure: libitum diet and waiting list control group Procedure: Early arthroscopic partial menisectomy group Procedure: delayed APM group recruit participants with symptoms lasting for more than 6 months	N/A

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

Study Type:

Interventional

Actual Enrollment :

189 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

First Affilated Hospital of Jinzhou Medical University

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calorie restricted diet and excecise intervention 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.	Dietary Supplement: Calorie restricted diet and exercise intervention 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.
Experimental: 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.	Procedure: libitum diet and waiting list control group 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.
Experimental: Early APM group Early APM group participants received APM with syndrome within 3 to 6 months	Procedure: Early arthroscopic partial menisectomy group Early APM group participants received APM with syndrome within 3 to 6 months
Experimental: delayed APM group recruit participants with symptoms lasting for more than 6 months delayed APM group recruit participants with symptoms lasting for more than 6 months	Procedure: delayed APM group recruit participants with symptoms lasting for more than 6 months delayed APM group recruit participants with symptoms lasting for more than 6 months

Outcome Measures

Primary Outcome Measures

Knee KOOS4 [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) [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). [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 [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 [up to 12 months]
height in meters
weight [up to 12 months]
weight in kilograms
BMI [up to 12 months]
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2
waist circumstance [up to 12 months]
waist circumstance in centimeter
Kellgren-Lawrence grade [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 [up to 12 months]
systolic blood pressure in mm Hg
diastolic blood pressure [up to 12 months]
diastolic blood pressure in mm Hg
triglyceride [up to 12 months]
triglyceride in mmol/L
HDL-C [up to 12 months]
high-density lipoprotein cholesterol in mmol/L
LDL-C [up to 12 months]
low-density lipoprotein cholesterol in mmol/L
fast blood glucose [up to 12 months]
fast blood glucose in mmol/L
total Cholesterol [up to 12 months]
total Cholesterol in mmol/L
β-2 microglobulin [up to 12 months]
β-2 microglobulin in mg/L
diabetes history [up to 12 months]
diabetes history
cardio vascular disease history [up to 12 months]
cardio vascular disease history
hypertension history [up to 12 months]
hypertension history
Lysholm knee score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;