Metabolic Syndrome and Degenerate Meniscus Tears

Metabolic Syndrome Clinical Trial

Official title:

First Affilated Hospital of Jinzhou Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837456
• Other study ID #: FirstJingzhou
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: The First People's Hospital of Jingzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Meniscus; Degeneration
• Metabolic Syndrome
• Syndrome

Intervention

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.
• Early arthroscopic partial menisectomy group
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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Jingzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	height	height in meters	up to 12 months
Primary	weight	weight in kilograms	up to 12 months
Primary	BMI	BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2	up to 12 months
Primary	waist circumstance	waist circumstance in centimeter	up to 12 months
Primary	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
Primary	systolic blood pressure	systolic blood pressure in mm Hg	up to 12 months
Primary	diastolic blood pressure	diastolic blood pressure in mm Hg	up to 12 months
Primary	triglyceride	triglyceride in mmol/L	up to 12 months
Primary	HDL-C	high-density lipoprotein cholesterol in mmol/L	up to 12 months
Primary	LDL-C	low-density lipoprotein cholesterol in mmol/L	up to 12 months
Primary	fast blood glucose	fast blood glucose in mmol/L	up to 12 months
Primary	total Cholesterol	total Cholesterol in mmol/L	up to 12 months
Primary	ß-2 microglobulin	ß-2 microglobulin in mg/L	up to 12 months
Primary	diabetes history	diabetes history	up to 12 months
Primary	cardio vascular disease history	cardio vascular disease history	up to 12 months
Primary	hypertension history	hypertension history	up to 12 months
Primary	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