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Roles of Uremic Toxins in Uremic Sacropenia

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ClinicalTrials.gov Identifier: NCT03060590
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Tungs' Taichung Metroharbour Hospital

Brief Summary:

Background. In advanced chronic kidney disease (CKD), multiple metabolic and nutritional abnormalities may contribute to the impairment of skeletal muscle mass and function thus predisposing patients to the condition of sarcopenia. Herein, we aim to investigate the association of uremic toxins and sacropenia. In addition, the prevalence and mortality predictive power of sarcopenia, defined by different methods, in a cohort of hemodialysis patients.

Methods. We plan to evaluate 300 HD patients. Sarcopenia was defined as reduced muscle function assessed by handgrip strength (HGS <30th percentile of a population-based reference adjusted for sex and age) plus diminished muscle mass assessed by different methods: (i) midarm muscle circumference (MAMC) <90% of reference value (A), (ii) muscle wasting by DEXA (B) and (iii) reduced skeletal muscle mass index (<10.76 kg/m² men; <6.76 kg/m² women) estimated by bioelectrical impedance analysis (BIA) (C). Serum levels of 3 established uremic toxins such as indoxyl sulfate, p-cresol and hippuric acid will be measured. Besides, various relevant inflammatory markers will also be assessed. Patients will be followed for up to 3 years for all-cause mortality.


Condition or disease
Sarcopenia

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Association of Uremic Toxins and Sacropenia in Hemodialysis Patients
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 31, 2020



Primary Outcome Measures :
  1. Presence of Sarcopenia [ Time Frame: 3 years ]
    To evaluate the association of sacropenia defined according to 1. Low muscle mass 2. Low muscle strength 3. Low physical performance and serum levels of some uremic toxins such as indoxyl sulfate, p-cresol and hippuric acid will be measured.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hemodialysis (HD) patients
Criteria

Inclusion Criteria:

  • Both sexes aged between 20-90 years. Received stable hemodialysis at least 3 months. Written informed consent.

Exclusion Criteria:

  • clinical signs of acute infection during the month preceding the inclusion, active cancer or liver disease at the time of evaluation, previous diagnosis of immunological diseases and unwillingness to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060590


Locations
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Taiwan
Tungs' Taichung MetroHarbour Hospital
Taichung, Taiwan
Sponsors and Collaborators
Tungs' Taichung Metroharbour Hospital
Investigators
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Principal Investigator: Paik Seong Lim, PhD Tungs' Taichung Metroharbour Hospital
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Responsible Party: Tungs' Taichung Metroharbour Hospital
ClinicalTrials.gov Identifier: NCT03060590    
Other Study ID Numbers: 105055
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tungs' Taichung Metroharbour Hospital:
sarcopenia, uremic toxins
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical