Loading search results
Sponsor study identifier
interventional
42
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
November 30, 2019
Actual (reported)Study Completion
November 30, 2019
Actual (reported)Cardiovascular disease (CVD) is prevalent in patients with chronic kidney disease (CKD) and is associated with extremely poor prognosis. Traditional risk factors for the general population, such as diabetes mellitus, high blood pressure, and dyslipidemia, are more common in patients with CKD but cannot fully explain the increased risk of this population. New evidence suggests that the uremic milieu itself plays a critical role in the development and progression of CVD. The gut microbiota is markedly altered in CKD, with overgrowth of bacteria that produce uremic toxins. Indoxyl sulfate (IS) is among the most representative gut-derived uremic toxins and has been most frequently implicated as a contributor to the pathogenesis of CVD in CKD. IS is converted from indole, a gut bacteria metabolite of dietary tryptophan, by two hepatic enzymes, CYP2E1 and SULT1A1. The majority of studies have assessed IS toxicity in cultured cells and animal models. However, human data have been conflicting and the benefit of using orally administered adsorbents to reduce IS levels in unselected CKD patients was not supported by results from the recent randomized controlled trials. IS levels may fluctuate widely from time to time with dietary intakes. The investigators hypothesize that a postprandial IS concentration may more reflect its toxicity than a single time point (fasting or predialysis IS) concentration measured in clinical studies. Therefore, the investigators plan to establish an oral tryptophan challenge test (OTCT) by using an oral loading of 2 gm tryptophan to simulate the postprandial increase of plasma IS. The investigators will recruit 60 healthy volunteers to undergo OTCT. A pharmacokinetic study of IS after the OTCT will be performed in 20 of them to verify and simplify the design of OTCT protocol. The results of OTCT will be integrated with whole metagenome analysis of fecal microbiota and genetic polymorphism analysis of CYP2E1 and SULT1A1 to explore the mechanisms of IS production. In addition to the known genes in microbe produces indoles, other supporting bacteria or genes will be examined by using metagenomic shotgun sequencing data.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2019
Actual (reported)October 1, 2019
Actual (reported)October 7, 2019
Actual (reported)November 30, 2019
Actual (reported)November 30, 2019
Actual (reported)Indoxyl sulfate
serum and urine indoxyl sulfate concentration measurement
the area under curve of serum and urine indoxyl sulfate within 72 hours
Indole-3-acetic acid
the area under curve of serum and urine Indole-3-acetic acid within 72 hours
All participants are introduced to receive tryptophan loading test.
2g tryptophan loading once
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Taipei Tzu Chi Hospital
New Taipei City, 231, Taiwan
Ting-Yun Lin, MD.
Taichung Tzu Chi Hospital
42 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2019
First Posted
October 7, 2019
Study Start
October 1, 2019
Contact the study team to confirm eligibility.
Primary Completion
November 30, 2019
Actual (reported)Study Completion
November 30, 2019
Actual (reported)Last Updated
December 10, 2019
Record last verified: 2019-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: