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NCT Number: NCT04837456

Metabolic Syndrome and Degenerate Meniscus Tears

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.

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Key information

Conditions

Metabolic Syndrome Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Meniscus; Degeneration Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Calorie restricted diet and exercise intervention

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

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 arthroscopic partial menisectomy group

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

Procedure

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

Primary outcomes

  1. Knee KOOS4

    Time frame: 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)

  2. the scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 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.

  3. The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC).

    Time frame: 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.

  4. The WOMET score

    Time frame: 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.

  5. height

    Time frame: up to 12 months

    height in meters

  6. weight

    Time frame: up to 12 months

    weight in kilograms

  7. BMI

    Time frame: up to 12 months

    BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2

  8. waist circumstance

    Time frame: up to 12 months

    waist circumstance in centimeter

  9. Kellgren-Lawrence grade

    Time frame: 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.

  10. systolic blood pressure

    Time frame: up to 12 months

    systolic blood pressure in mm Hg

  11. diastolic blood pressure

    Time frame: up to 12 months

    diastolic blood pressure in mm Hg

  12. triglyceride

    Time frame: up to 12 months

    triglyceride in mmol/L

  13. HDL-C

    Time frame: up to 12 months

    high-density lipoprotein cholesterol in mmol/L

  14. LDL-C

    Time frame: up to 12 months

    low-density lipoprotein cholesterol in mmol/L

  15. fast blood glucose

    Time frame: up to 12 months

    fast blood glucose in mmol/L

  16. total Cholesterol

    Time frame: up to 12 months

    total Cholesterol in mmol/L

  17. β-2 microglobulin

    Time frame: up to 12 months

    β-2 microglobulin in mg/L

  18. diabetes history

    Time frame: up to 12 months

    diabetes history

  19. cardio vascular disease history

    Time frame: up to 12 months

    cardio vascular disease history

  20. hypertension history

    Time frame: up to 12 months

    hypertension history

  21. Lysholm knee score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Jingzhou

Other

Registry information

Official study title

First Affilated Hospital of Jinzhou Medical University

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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