Association of Uremic Toxins and Sacropenia in Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Presence of Sarcopenia
Study Overview
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.
Detailed Description
Patients and Methods
This study will included 300 consecutive patients receiving maintenance hemodialysis at the outpatient dialysis center of the Tungs Taichung Metroharbour Hospital, Taichung Taiwan. Recruitment will start after approval of the Ethics Committee of our hospital. Exclusion criteria were age of <20 and >90 years, 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. Physician will perform a complete chart review and interviewed each patient regarding their clinical history.
All MHD patients enrolled in our study will be tested with DEXA and bioelectrical impedance analysis (BIA) and grip strength. Demographic data was collected and anthropometric measurement such as mid-arm muscle circumference (MAMC) calf circumference, and laboratory examination are conducted.
Handgrip strength
Muscle strength is assessed in the dominant hand using a Jamar hand dynamometer (Lafayette Instrument Company, USA). Patients are first familiarized with the device and were then examined standing with both arms extended sideways from the body with the dynamometer facing away from the body. Patients were instructed to grip the dynamometer with the maximum strength in response to a voice command, and the highest value of three measurements was considered for the study. Handgrip strength (HGS) values under the 30th percentile from a specific-population reference value adjusted for age and sex were considered as reduced.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 20 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported