NCT05479331

Brief Summary

This study explores the risk factors for sarcopenia in patients with chronic kidney disease and the effects of sarcopenia on cardiovascular disease. Treatment of sarcopenia and cardiovascular complications provides a basis for improving the quality of life and survival of patients with chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

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

January 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
Last Updated

August 1, 2022

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

July 27, 2022

Last Update Submit

July 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Epicardial adipose tissue measured by ultrasound color doppler

    EAT is defined as a fat depot that exists on the surface of the myocardium,which plays a detrimental role in our health. EAT would be measured by ultrasound color doppler.

    the day when being recruited

  • Intima-media thickness measured by ultrasound color doppler

    IMT of carotid arteries, as assessed noninvasively by carotid ultrasonography, is a useful measure of preclinical atherosclerosis. Carotid IMT has been found to predict future risk of cardiovascular disease.IMT would be measured by ultrasound color doppler.

    the day when being recruited

Secondary Outcomes (1)

  • Baseline demographic, clinical and laboratory characteristics

    the day when being recruited

Study Arms (2)

sarcopenia

CKD patients with sarcopenia, meeting the following two criteria (1) male LTI (lean tissue index)\< 7.0 kg/m2, female LTI \< 5.7 kg/m2; (2) Male HGS)(handgrip strength \< 26 kg, female HGS \< 18 kg.

non-sarcopenia

CKD patients with non-sarcopenia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic kidney disease

You may qualify if:

  • Patients presented by the Nephrology Center during August 2019 and March 2021
  • Age 18-75 years;
  • Patients with CKD2 or above (eGFR≤60 ml/(min 1.73m2)

You may not qualify if:

  • There are contraindications to bioelectrical impedance spectroscopy (BIS) . examination, such as amputation, metal implants in the body, etc.;
  • Complicated with other serious diseases, such as malignant tumors, cirrhosis, systemic infections, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baoshan Site of Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

SarcopeniaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Jiangzi Yuan, MD

    Baoshan Site of Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician of Nephrology

Study Record Dates

First Submitted

July 27, 2022

First Posted

July 29, 2022

Study Start

January 1, 2020

Primary Completion

March 31, 2021

Study Completion

December 31, 2021

Last Updated

August 1, 2022

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations