NCT04309201

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

March 12, 2020

Last Update Submit

January 29, 2021

Conditions

Keywords

Insulin resistanceSarcopeniaβ-aminoisobutyric acid

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

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

SarcopeniaInsulin Resistance

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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

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

Locations