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Isotope Tracer

Glycolate Metabolism Study in Healthy Subjects

N/A

Recruiting

Led By Sonia Fargue, M.D., Ph.D.

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mentally competent adults, able to read and comprehend the consent form

18-75 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 5 of dietary control

Awards & highlights

Study Summary

This trial will study how well the metabolism of glycolate affects the removal of oxalate in urine of healthy people.

Who is the study for?

This trial is for mentally competent adults aged 18-75, with a BMI between 19 and 40, who are in good health as determined by medical history and blood tests. They must have completed acceptable urine collections twice for screening. It's not for pregnant or lactating individuals, those planning to become pregnant soon, or anyone with liver, kidney, bowel or endocrine diseases.Check my eligibility

What is being tested?

The study is testing how the body processes a substance called glycolate into another substance called oxalate using different methods: an IV infusion, an oral dose of labeled glycolate (13C2-Glycolate), and while on a low-oxalate diet. The goal is to understand how this metabolism contributes to the amount of oxalate in urine.See study design

What are the potential side effects?

Since this trial involves healthy subjects and non-pharmaceutical interventions like special diets and administration of a naturally occurring compound (glycolate), side effects are expected to be minimal but could include discomfort from IV insertion or potential reactions at the site of infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and make decisions about my health care.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 5 of dietary control

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 5 of dietary control

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 5 of dietary control for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Chromatography

Urinary oxalate measured by ion chromatography coupled with mass spectrometry

Secondary outcome measures

Urinary creatinine

Urinary glycolate measured by ion chromatography coupled with mass spectrometry

Trial Design

3Treatment groups

Experimental Treatment

Group I: Single Oral Dose of 13C2-GlycolateExperimental Treatment2 Interventions

Subjects will consume a controlled diet for 5 days total. On Days 3 and 4, subjects will collect 24 hour urines. On Day 5, they will come to the Clinical Research Unit (CRU) in the fasted state for a visit lasting from 7:00 am to 2:30 pm. At 8:30 am, subjects will ingest the carbon-13 glycolate, dissolved in to 50 ml (about 1/4 cup) of water. From 7:30 am to 2:30 pm, urine collections will occur hourly. At 8:30 am, intravenous (IV) blood samples will be taken every fifteen minutes until 9:30 am, every half hour from 9:30 am to 10:30 am, and then finally hourly from 10:30 am to 2:30 pm . Subjects will receive a meal at 2:30 pm, thus concluding the CRU visit. At home, subjects will collect timed urine until the next morning to be returned to the CRU.

Group II: Single Intravenous Dose of 13C2-GlycolateExperimental Treatment2 Interventions

Subjects will consume a controlled diet for 5 days total. On Days 3 and 4, subjects will collect 24 hour urines. On Day 5, they will come to the Clinical Research Unit (CRU) in the fasted state for a visit lasting from 7:00 am to 2:30 pm. An intravenous (IV) catheter will be placed in a vein on the back of the hand at 8:30 am for a single dose of carbon-13 glycolate to be administered. From 7:30 am to 2:30 pm, urine collections will occur hourly. At 8:30 am, IV blood samples will be taken every fifteen minutes until 9:30 am, every half hour from 9:30 am to 10:30 am, and then finally hourly from 10:30 am to 2:30 pm . Subjects will receive a meal at 2:30 pm, thus concluding the CRU visit. At home, subjects will collect timed urine until the next morning to be returned to the CRU.

Group III: Constant Infusion of 13C2-GlycolateExperimental Treatment2 Interventions

Subjects will consume a controlled diet for 5 days total. On Days 3 and 4, subjects will collect 24 hour urines. On Day 5, they will come to the Clinical Research Unit (CRU) in the fasted state for a visit lasting from 7:00 am to 5:30 pm. An intravenous (IV) catheter will be placed in a vein on the back of the hand at 7:30 am for the carbon 13 glycolate infusion which will occur at a constant rate for 10 hours, following a priming dose. From 7:30 am to 5:30 pm, urine collections will occur hourly, and from 8:30 am to 5:30 pm, IV blood collections will occur every half hour. Subjects will receive a meal at 5:30 pm, thus concluding the CRU visit. At home, subjects will collect timed urine until the next morning to be returned to the CRU.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,587 Previous Clinical Trials

2,280,257 Total Patients Enrolled

Sonia Fargue, M.D., Ph.D.Principal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

Media Library

13C2-Glycolate (Isotope Tracer) Clinical Trial Eligibility Overview. Trial Name: NCT04437225 — N/A

Healthy Subjects Research Study Groups: Constant Infusion of 13C2-Glycolate, Single Oral Dose of 13C2-Glycolate, Single Intravenous Dose of 13C2-Glycolate

Healthy Subjects Clinical Trial 2023: 13C2-Glycolate Highlights & Side Effects. Trial Name: NCT04437225 — N/A

13C2-Glycolate (Isotope Tracer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04437225 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this medical research experiment?

"This research project is actively enrolling patients, as observed on clinicaltrials.gov; the trial started being advertised on March 12th 2020 and was last updated June 1st 2022."

Answered by AI

Is there a minimum age requirement for participation in this experiment?

"As per the qualification requirements for this study, eligible patients must be aged 18-75. In contrast, there are 50 clinical trials specifically targeting individuals younger than 18 and 371 open to those over 65 years old."

Answered by AI

To what extent is the participant pool engaged in this investigation?

"Affirmative. According to clinicaltrials.gov, this study is still recruiting volunteers and was first listed on March 12th 2020. The latest update was made on June 1st 2022 and the trial seeks 15 individuals at a single location."

Answered by AI

What criteria must prospective participants meet to join this investigation?

"15 individuals aged 18-75 and of healthy BMI (19-40) are being recruited for this study. Furthermore, participants must provide their medical history, reported medications, a complete blood metabolic profile to prove good health."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Renal Metabolism of Glycolate to Oxalate

Sonia Fargue 2020. "Renal Metabolism of Glycolate to Oxalate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04437225.