NCT04921202

Brief Summary

Studies have suggested that Obese patients with metabolic syndrome(MetS)were correlated with knee joint degeneration and osteoarthritis. However, no studies demonstrate the relationship between obese patients with metabolic syndrome and degenerate meniscus lesions and its knee function.The aim is to detect the correlation between obese patients with metabolic syndrome and degenerate meniscus injuries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

2.8 years

First QC Date

June 3, 2021

Last Update Submit

June 8, 2021

Conditions

Keywords

Metabolic Syndromedegenerate meniscus lesionsobesityknee function

Outcome Measures

Primary Outcomes (2)

  • the Knee injury and Osteoarthritis Outcome Score (KOOS) total

    The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and 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 month

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

    The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score to determine the meniscus function. The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear\[36, 37\] \[38\]. The questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.

    up to 12 month

Secondary Outcomes (6)

  • KOOS Pain subscale

    up to 12 month

  • Symptoms subscale

    up to 12 month

  • Activities of Daily Living subscale

    up to 12 month

  • Sport and Recreation function subscale

    up to 12 month

  • knee-related Quality of Life subscale

    up to 12 month

  • +1 more secondary outcomes

Study Arms (2)

without metabolic syndrome and BMI<24

100 volunteers aged between 35-70 years old with body mass index(BMI)\<24 without Metabolic syndrome

Metabolic Syndrome with BMI>27

80 Metabolic syndrome patients with BMI\>27 were included in the study

Other: Metabolic syndrome and meniscus injuries

Interventions

Metabolic syndrome

Metabolic Syndrome with BMI>27

Eligibility Criteria

Age35 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

participants from Jinzhou City, west of Liaoning Province

You may qualify if:

  • Must be age between 35 and 70 years old;
  • Clinical diagnosis of metabolic syndrome;
  • BMI score more than 27 or less than 24
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

Location

MeSH Terms

Conditions

Metabolic SyndromeObesity, AbdominalObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hongyu Wang, Doctor

    The First People's Hospital of Jingzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief residents

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 10, 2021

Study Start

June 1, 2017

Primary Completion

March 25, 2020

Study Completion

March 1, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations