Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Association of Uremic Sarcopenia and Mitochondrial Copy Number and Its Clinical Correlates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03929458
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Tungs’ Taichung Metroharbour Hospital

Brief Summary:
Sarcopenia is the decline of muscle mass and strength with age. Evidence suggests that oxidative stress and molecular inflammation play important roles in age-related muscle atrophy. The two factors may interfere with the balance between protein synthesis and breakdown, cause mitochondrial dysfunction, and induce apoptosis. Sarcopenia, inflammation and oxidative stress is highly prevalent in hemodialysis patients and may contribute to mortality. The copy number of mitochondrial DNA (mtDNA) is affected by oxidative stress in blood circulation. This study aimed to test whether mtDNA copy number correlates with oxidative stress and some uremic toxins in nondiabetic hemodialysis(HD) patients. 200 nondiabetic hemodialysis patients and 50 healthy subjects will be enrolled. This study will be performed to investigate quantitative changes in mtDNA occur in HD patients with and without sarcopenia. Copy number of mtDNA in leukocyte DNA is determined by real-time polymerase chain reaction in HD patients and 50 age- and sex-matched control subjects. In addition, correlation of the alterations of albumin redox status, 8-isoprostane, plasma IL-6 ,LBP and TNF-a and as well as various uremic toxins will be performed.

Condition or disease
Sarcopenia Mitochondrial DNA

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Association of Uremic Sarcopenia and Mitochondrial Copy Number and Its Clinical Correlates in Taiwanese Hemodialysis Patients
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019



Primary Outcome Measures :
  1. Determination of mtDNA/nDNA Ratio as a measure of mtDNA Content [ Time Frame: 1 years ]
    The copy number of the mtDNA and the nDNA is calculated using the threshold cycle number (Ct) and intrapolating from the standard curve. The ratio of the copy number of mtDNA to the copy number of nDNA is measurement of mtDNA content.


Secondary Outcome Measures :
  1. Plasma uremic toxins analysis [ Time Frame: 1 years ]
    ndoxyl sulfate (IS) and para-cresol (p-cresol) belong to the group of protein-bound uremic toxins that are poorly cleared by dialysis and are associated with poor clinical outcomes.the group of protein-bound uremic toxins that are poorly cleared by dialysis and are associated with poor clinical outcomes.

  2. Total of 8-iso-PGF2-alpha Analysis [ Time Frame: 1 years ]
    Total 8-iso-PGF2-alpha concentrations in plasma were measured by a specific enzyme immunoassay (EIA) kit

  3. Analysis of biomarkers of IL-6 [ Time Frame: 1 years ]
    The IL-6 was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods

  4. Analysis of biomarkers of TNF-α [ Time Frame: 1 years ]
    The TNF-α was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods

  5. Analysis of biomarkers of Liposaccharide-binding protein (LBP) [ Time Frame: 1 years ]
    The LBP was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods

  6. Measurement of the Albumin Redox State [ Time Frame: 1 years ]
    the fractions of HMA, HNA-1, and HNA-2 to total HSA were measured using HPLC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with severe infections, severe heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring oral nutrition supplements;
  • Inability to follow protocol.
  • Pregnancy or wishing/trying to get pregnant

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): NCT03929458


Contacts
Layout table for location contacts
Contact: Paik Seong Lim, PhD +886935045292 jamespslim@gmail.com

Sponsors and Collaborators
Tungs’ Taichung Metroharbour Hospital
Investigators
Layout table for investigator information
Principal Investigator: Paik Seong Lim, PhD Tungs’ Taichung Metroharbour Hospital

Layout table for additonal information
Responsible Party: Tungs’ Taichung Metroharbour Hospital
ClinicalTrials.gov Identifier: NCT03929458     History of Changes
Other Study ID Numbers: 107061
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: April 2019

Layout table for additional information
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:
oxidative stress
Sarcopenia
copy number of mitochondrial DNA (mtDNA)

Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms