Metabolic Syndrome and Degenerate Meniscus Tears

NCT04837456 | Completed DMC

• 1 other identifier: FirstJingzhou
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Meniscus; Degeneration

Keywords

Metabolic Syndrome; degenerate meniscus lesions; Calorie restricted diet; exercise; arthroscopic partial meniscectomy

Outcome Measures

Primary Outcomes (21)

• Knee KOOS4

  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)

  up to 12 months

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

  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.

  up to 12 months

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

  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.

  up to 12 months

• The WOMET score

  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.

  up to 12 months

• height

  height in meters

  up to 12 months

• weight

  weight in kilograms

  up to 12 months

• BMI

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

  up to 12 months

• waist circumstance

  waist circumstance in centimeter

  up to 12 months

• Kellgren-Lawrence grade

  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.

  up to 12 months

• systolic blood pressure

  systolic blood pressure in mm Hg

  up to 12 months

• diastolic blood pressure

  diastolic blood pressure in mm Hg

  up to 12 months

• triglyceride

  triglyceride in mmol/L

  up to 12 months

• HDL-C

  high-density lipoprotein cholesterol in mmol/L

  up to 12 months

• LDL-C

  low-density lipoprotein cholesterol in mmol/L

  up to 12 months

• fast blood glucose

  fast blood glucose in mmol/L

  up to 12 months

• total Cholesterol

  total Cholesterol in mmol/L

  up to 12 months

• β-2 microglobulin

  β-2 microglobulin in mg/L

  up to 12 months

• diabetes history

  diabetes history

  up to 12 months

• cardio vascular disease history

  cardio vascular disease history

  up to 12 months

• hypertension history

  hypertension history

  up to 12 months

• Lysholm knee score

  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.

  up to 12 months

Study Arms (4)

Calorie restricted diet and excecise intervention

EXPERIMENTAL

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.

Dietary Supplement: Calorie restricted diet and exercise intervention

libitum diet and waiting list control group

EXPERIMENTAL

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: libitum diet and waiting list control group

Early APM group

EXPERIMENTAL

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

Procedure: Early arthroscopic partial menisectomy group

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

EXPERIMENTAL

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

Interventions

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.

Calorie restricted diet and excecise intervention

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.

libitum diet and waiting list control group

Early arthroscopic partial menisectomy group PROCEDURE

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

Early APM group

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

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

Eligibility Criteria

• Age: 35 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be age between 35 and 70 years old;
• Clinical diagnosis of metabolic syndrome;
• Clinical diagnosis of 3 grade degneration meniscus leisons;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First People's Hospital of Jingzhou: lead

Study Sites (1)

First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

Location

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hongyu Wang, Doctor

  The First People's Hospital of Jingzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief residents

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: April 8, 2021
• Study Start: June 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CN (1)