Metabolic Syndrome and Degenerate Meniscus Tears

NCT ID: NCT04837456

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-03-01

Brief Summary

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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

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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

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Metabolic Syndrome Meniscus; Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Calorie restricted diet and exercise intervention

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type EXPERIMENTAL

libitum diet and waiting list control group

Intervention Type PROCEDURE

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.

Early APM group

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

Group Type EXPERIMENTAL

Early arthroscopic partial menisectomy group

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type PROCEDURE

Early arthroscopic partial menisectomy group

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First People's Hospital of Jingzhou

OTHER

Sponsor Role lead

Responsible Party

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Hongyu Wang

chief residents

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongyu Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First People's Hospital of Jingzhou

Locations

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First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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FirstJingzhou

Identifier Type: -

Identifier Source: org_study_id

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