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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

Must not have

Aged <18 or >75

BMI <19 or >40

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 5 of dietary control

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 or older than 75.

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My BMI is either below 19 or above 40.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chromatography

Urinary oxalate measured by ion chromatography coupled with mass spectrometry

Secondary study objectives

Urinary creatinine

Urinary glycolate measured by ion chromatography coupled with mass spectrometry

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met