HealthyNCT04437225
Renal Metabolism of Glycolate to Oxalate
A study testing Primed, continuous intravenous infusion of 13C2-Glycolate, Bolus intravenous infusion of 13C2-Glycolate and Oral bolus administration of 13C2-Glycolate in people with Healthy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will determine the contribution of glycolate metabolism to urinary oxalate excretion in healthy subjects, using carbon 13 isotope glycolate tracer technique and a low-oxalate controlled diet. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Primed, continuous intravenous infusion of 13C2-Glycolate, Bolus intravenous infusion of 13C2-Glycolate and Oral bolus administration of 13C2-Glycolate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2020to 1 Dec 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mentally competent adults, able to read and comprehend the consent form
- 18-75 years of age
- Body Mass Index (BMI) between 19 and 40
- In good health as judged from a medical history, reported medications, and a complete blood metabolic profile
- Acceptable 24 hour urine collections (performed twice for screening)
Who cannot join
- History of any hepatic, renal, bowel, or endocrine disease or any other condition that may influence the absorption, transport or urine excretion of ions
- Abnormal urine chemistries or blood metabolic profiles
- Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
- Pregnancy, intention to become pregnant in the near future, or lactation
- Aged <18 or >75
- BMI <19 or >40
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
This study will determine the contribution of glycolate metabolism to urinary oxalate excretion in healthy subjects, using carbon 13 isotope glycolate tracer technique and a low-oxalate controlled diet.
Read the detailed description
It is known that glycolate, an intermediary molecule in normal metabolism, can be converted into oxalate. The origin of urinary oxalate is of interest as calcium oxalate is a main component of kidney stones. In the rare disease primary hyperoxaluria, excessive production of oxalate by the body results in frequent kidney stones and can cause loss of kidney function. Primary hyperoxaluria is caused by deficiencies in one of several enzymes involved in the glycolate pathway.
This study will seek to determine how much oxalate is formed from glycolate in normal subjects. After consuming a controlled diet, subjects will either ingest or have an intravenous infusion of carbon 13 glycolate, a stable isotope of glycolate that can be tracked and will also label downstream metabolic products. Blood and urine samples will be assessed for their amounts of labeled glycolate and labeled oxalate to provide an accurate measure of how much oxalate is made from normal glycolate breakdown in healthy human subjects.
- Conditions
- Healthy
- Being tested
- Low oxalate controlled Diet, Primed, continuous intravenous infusion of 13C2-Glycolate, Bolus intravenous infusion of 13C2-Glycolate, Oral bolus administration of 13C2-Glycolate
- Keywords
- oxalate metabolism, kidney stones, glycolate, isotope tracer study, urolithiasis, oxalate
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low oxalate controlled DietDietary supplement
Participants will consume a diet that is controlled in its contents of protein, carbohydrates, fat, calcium, oxalate, vitamin C and sodium. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.
Primed, continuous intravenous infusion of 13C2-GlycolateOther
Also called Constant infusion of 13C2-Glycolate
Participants will receive a continuous intravenous administration of carbon-13 glycolate, a naturally occurring form of glycolate, over the course of several hours until steady-state is achieved, using an IV catheter.
Bolus intravenous infusion of 13C2-GlycolateOther
Also called Single intravenous dose of 13C2-Glycolate
Participants will receive a bolus intravenous administration of carbon-13 glycolate, a naturally occurring form of glycolate, using an IV catheter.
Oral bolus administration of 13C2-GlycolateOther
Also called Single oral dose of 13C2-Glycolate
Participants will orally ingest a single dose of carbon-13 glycolate, a naturally occurring form of glycolate.
| Study group | Role | What they receive |
|---|---|---|
| Constant Infusion of 13C2-Glycolate | Experimental | 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. Receives: Dietary Supplement: Low oxalate controlled Diet; Other: Primed, continuous intravenous infusion of 13C2-Glycolate |
| Single Intravenous Dose of 13C2-Glycolate | Experimental | 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. Receives: Dietary Supplement: Low oxalate controlled Diet; Other: Bolus intravenous infusion of 13C2-Glycolate |
| Single Oral Dose of 13C2-Glycolate | Experimental | 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. Receives: Dietary Supplement: Low oxalate controlled Diet; Other: Oral bolus administration of 13C2-Glycolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary oxalate measured by ion chromatography coupled with mass spectrometry
Measurement of carbon 13 labeled and unlabeled urinary oxalate following carbon 13 glycolate administration, after equilibration under a low-oxalate diet.
Measured: day 5 of dietary control
Plasma glycolate measured by ion chromatography coupled with mass spectrometry
Measurement of carbon 13 labeled and unlabeled plasma glycolate following carbon 13 glycolate administration, after equilibration under a low-oxalate diet.
Measured: day 5 of dietary control
Secondary outcomes (2)
Urinary creatinine
Baseline assessment of 24hr urinary creatinine under controlled low-oxalate diet.
Measured: day 5 of dietary control
Urinary glycolate measured by ion chromatography coupled with mass spectrometry
Measurement of carbon 13 labeled and unlabeled urinary glycolate following carbon 13 glycolate administration, after equilibration under a low-oxalate diet.
Measured: day 5 of dietary control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start12 Mar 2020
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subject will undergo the gold-standard technique of steady-state intravenous infusion of 13-glycolate administration. Selected subjects will also undergo other modified modalities of 13-glycolate administration.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Fargue, University of Alabama at Birmingham
- Investigators
- Sonia Fargue, M.D., Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437225
- Sponsor's protocol ID
- IRB160505004-GLI
- Other IDs
- K01DK114332, UAB
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2020
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No