Metabolic Syndrome Clinical Trial
Official title:
First Affilated Hospital of Jinzhou Medical University
Verified date | April 2021 |
Source | The First People's Hospital of Jingzhou |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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; |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Jinzhou Medical University | Jinzhou | Liaoning |
Lead Sponsor | Collaborator |
---|---|
The First People's Hospital of Jingzhou |
China,
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 |
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