Chronic Mesenteric Ischemia Breath Testing
Heavy Isotope-labeled-butyrate and Glucose in Breath Testing to Detect Mesenteric Ischemia, a Proof-of-concept Study in Healthy Volunteers.
1 other identifier
interventional
20
1 country
1
Brief Summary
Background and aims: A gold standard diagnostic test to diagnose chronic mesenteric ischemia is currently lacking. Isotope labelled-butyrate and glucose breath testing could theoretically quantify mucosal oxygen consumption and thereby detect ischemia, since oxygen is needed to absorb and metabolize butyrate and glucose, and distinguish aerobic/anaerobic intestinal epithelial metabolism. Here we aim to test this notion and compare results to conventional biomarkers. Methods: Healthy volunteers were randomized into two control groups and two intervention groups, each consisting of five volunteers receiving either oral 13C -butyrate or 13C -glucose. The control groups performed breath tests without any physical exercise. The intervention groups performed a 30 minutes standardized bicycle exercise test, which has been proven to elicit mesenteric ischemia. Breath samples of expired 13CO2 were collected during a period of 4 hours and results were contrasted to measurements of biomarkers in peripheral blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
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 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedSeptember 5, 2023
August 1, 2023
1 month
July 26, 2023
August 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The median concentrations of measured 13CO2
The median concentrations of measured 13CO2 at each time point where compared within the four groups and statistically tested with a Mann - Whitney U test.
At the following time points; baseline, 0.5, 1, 1.25 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5 and 4 hours (total of 12 time points) after ingestion of 13C-butyrate or 13C-glucose.
Study Arms (4)
13C -butyrate control group
PLACEBO COMPARATOR5 healthy volunteers performed the breath test without any psychical exercise
13C -butyrate intervention group
EXPERIMENTAL5 healthy volunteers performed the breath test with psychical exercise - bicycle test
13C -glucose control group
PLACEBO COMPARATOR5 healthy volunteers performed the breath test without any psychical exercise
13C -glucose intervention group
EXPERIMENTAL5 healthy volunteers performed the breath test with psychical exercise - bicycle test
Interventions
a solution containing butyrate of which 12C of the last 4 carbon positions of butyrate were replaced by 13C butyrate. Participants received 0.80 gram 13C-butyrate (7.3 mMol butyrate / 29 mMol 13C) dissolved in 50 mL water at baseline
a glucose solution in which all six 12C carbons were replaced by 13C D-Glucose. Participants received 0.75 gram 13C-glucose (4.2 mMol D-glucose/ 25 mMol 13C) dissolved in 50 mL water at baseline
Breath tests were performed at the following time points baseline, 0.5, 1, 1.25 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5 and 4 hours after ingestion of 13C-butyrate and 13C-glucose. Breath samples were obtained by blowing a single breath of air through a straw into a test tube. Two breath samples were collected at all mentioned time points. Measurement of 13CO2 is performed using mass spectrometry (IDMicro Breath, Compact Science Systems, Newcastle-Under-Lyme, United Kingdom) using procedures described earlier for galactose and methacetin breath tests, and expressed as an absolute increase in the 13CO2-to-12CO2 ratio in delta permil (δ‰).
The intervention groups performed a standardized bicycle ergometer exercise test of 30 minutes and semi-continuous peripheral blood lactate monitoring. The bicycle ergometer protocol consists of three phases. The first 10 minutes of exercise was used to gradually increase the workload until submaximal exercise intensity was reached which is defined as a circulating blood lactate level between 3 and 5.5 mmol/L. From minute 10 to 20 submaximal exercise intensity was maintained by adjusting the workload based on lactate measurements. Minute 20 to 30 was used to reach maximal exercise intensity, the workload was increased by 10% of the submaximal workload until exhaustion
Eligibility Criteria
You may qualify if:
- healthy volunteers without any gastrointestinal complaints
You may not qualify if:
- pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus Medical Center - Department of Gastroenterology
Rotterdam, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Bruno, prof.
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterologist
Study Record Dates
First Submitted
July 26, 2023
First Posted
September 5, 2023
Study Start
March 1, 2021
Primary Completion
April 1, 2021
Study Completion
August 1, 2021
Last Updated
September 5, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share