Insulin Resistance, Sarcopenia and Plasma BAIBA Levels
Relationship With Muscle Wasting and Insulin Resistance in a Group of Non-diabetic Hemodialysis Patients.
1 other identifier
observational
150
1 country
1
Brief Summary
Insulin resistance (IR) is an early metabolic alteration in chronic kidney disease (CKD) patients, becoming almost universal in those who reach the end stage of kidney failure. The skeletal muscle represents the primary site of IR in CKD, and alterations at sites beyond the insulin receptor are recognized as the main defect underlying IR in this condition. The etiology of IR in CKD is multifactorial in nature and may be secondary to disturbances that are prominent in renal diseases, including physical inactivity, chronic inflammation, oxidative stress, vitamin D deficiency, metabolic acidosis, anemia, adipokine derangement, and altered gut microbiome. IR has been solidly associated with intermediate mechanisms leading to cardiovascular (CV) disease in CKD including left ventricular hypertrophy, vascular dysfunction, and atherosclerosis. Recent studies have identified a muscle factor β-aminoisobutyric acid (BAIBA), which is produced by skeletal muscle during physical activity. BAIBA have been found to link with sedentary life style, abdominal obesity, and impairments in carbohydrate and lipid metabolism. A few studies have shown that BAIBA can protect from diet-induced obesity in animal models. It induces transition of white adipose tissue to a "beige" phenotype, which induces fatty acids oxidation and increases insulin sensitivity. While the exact mechanisms of BAIBA-induced metabolic effects are still not well understood, the aim of this study is want to study its relationship with muscle wasting and insulin resistance in a group of non-diabetic hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2020
CompletedFirst Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 1, 2021
January 1, 2021
10 months
March 12, 2020
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analysis of biomarkers of β-aminoisobutyric Acid( L-BAIBA) levels
BAIBA can protect from diet-induced obesity in animal models. It induces transition of white adipose tissue to a "beige" phenotype, which induces fatty acids oxidation and increases insulin sensitivity.
1 years
Secondary Outcomes (1)
Presence of Sarcopenia
1 years
Eligibility Criteria
hemodialysis (HD) patients
You may qualify if:
- Received stable hemodialysis at least 3 months
You may not qualify if:
- cancer
- heart failure
- severe liver disease
- chronic infection such diabetic foot
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tungs' Taichung MetroHarbour Hospital
Taichung, Taiwan
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paik Seong Lim, PhD
Tungs' Taichung Metroharbour Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 16, 2020
Study Start
March 10, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 1, 2021
Record last verified: 2021-01