Clinical trial NCT04837456: Metabolic Syndrome and Degenerate Meniscus Tears
Official title: First Affilated Hospital of Jinzhou Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Meniscus; Degeneration
Keywords: Metabolic Syndrome
degenerate meniscus lesions
Calorie restricted diet
exercise
arthroscopic partial meniscectomy
Lead sponsor: The First People's Hospital of Jingzhou
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 189
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Knee KOOS4
timeFrame: up to 12 months
measure: the scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: up to 12 months
measure: The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC).
timeFrame: up to 12 months
measure: The WOMET score
timeFrame: up to 12 months
measure: height
timeFrame: up to 12 months
measure: weight
timeFrame: up to 12 months
measure: BMI
timeFrame: up to 12 months
measure: waist circumstance
timeFrame: up to 12 months
measure: Kellgren-Lawrence grade
timeFrame: up to 12 months
measure: systolic blood pressure
timeFrame: up to 12 months
measure: diastolic blood pressure
timeFrame: up to 12 months
measure: triglyceride
timeFrame: up to 12 months
measure: HDL-C
timeFrame: up to 12 months
measure: LDL-C
timeFrame: up to 12 months
measure: fast blood glucose
timeFrame: up to 12 months
measure: total Cholesterol
timeFrame: up to 12 months
measure: β-2 microglobulin
timeFrame: up to 12 months
measure: diabetes history
timeFrame: up to 12 months
measure: cardio vascular disease history
timeFrame: up to 12 months
measure: hypertension history
timeFrame: up to 12 months
measure: Lysholm knee score
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinzhou
country: China
facility: First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
Study officials:
affiliation: The First People's Hospital of Jingzhou
name: Hongyu Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: