Metabolic Syndrome and Degenerate Meniscus Tears

Yangtze University

Status

Completed

Conditions

Meniscus; Degeneration

Metabolic Syndrome

Treatments

Procedure: Early arthroscopic partial menisectomy group

Procedure: libitum diet and waiting list control group

Dietary Supplement: Calorie restricted diet and exercise intervention

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04837456

FirstJingzhou

Details and patient eligibility

About

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.

Full 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.

Enrollment

189 patients

Sex

All

Ages

35 to 70 years old

Volunteers

Accepts 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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

189 participants in 4 patient groups

Calorie restricted diet and excecise intervention

Experimental group

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.

Treatment:

Dietary Supplement: Calorie restricted diet and exercise intervention

libitum diet and waiting list control group

Experimental group

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.

Treatment:

Procedure: libitum diet and waiting list control group

Early APM group

Experimental group

Description:

Early APM group participants received APM with syndrome within 3 to 6 months

Treatment:

Procedure: Early arthroscopic partial menisectomy group

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

Experimental group

Description:

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