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

NCT03929458 | Completed DMC

• 1 other identifier: 107061
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Mitochondrial DNA

Keywords

oxidative stress; Sarcopenia; copy number of mitochondrial DNA (mtDNA)

Outcome Measures

Primary Outcomes (1)

• Determination of mtDNA/nDNA Ratio as a measure of mtDNA Content

  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.

  1 years

Secondary Outcomes (6)

• Plasma uremic toxins analysis

  1 years

• Total of 8-iso-PGF2-alpha Analysis

  1 years

• Analysis of biomarkers of IL-6

  1 years

• Analysis of biomarkers of TNF-α

  1 years

• Analysis of biomarkers of Liposaccharide-binding protein (LBP)

  1 years

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 26, 2019
• Study Start: May 7, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

TW (1)