NCT04837456

Metabolic Syndrome and Degenerate Meniscus Tears

First Affilated Hospital of Jinzhou Medical University

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: The First People's Hospital of Jingzhou · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metabolic Syndrome
• Meniscus; Degeneration

Interventions

Type	Name	Description
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.
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.
PROCEDURE	Early arthroscopic partial menisectomy group	Early APM group participants received APM with syndrome within 3 to 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

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-03-01
• Completion: 2021-03-01
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: China