Understanding how glycolate affects oxalate levels in healthy individuals
Renal Metabolism of Glycolate to Oxalate
This study is testing how glycolate affects oxalate levels in healthy adults to learn more about how the body processes these substances and their role in kidney stone formation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04437225 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolism of glycolate and its contribution to urinary oxalate excretion in healthy adults. Participants will consume a controlled low-oxalate diet and receive carbon 13 labeled glycolate either through intravenous infusion or oral administration. Blood and urine samples will be collected to measure the levels of labeled glycolate and oxalate, providing insights into the metabolic pathway of glycolate in normal physiology. The findings could enhance understanding of oxalate metabolism and its implications for kidney stone formation.
Who should consider this trial
Good fit: Ideal candidates are mentally competent adults aged 18-75, with a BMI between 19 and 40, and in good health.
Not a fit: Patients with a history of hepatic, renal, bowel, or endocrine diseases, or those with abnormal metabolic profiles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding of kidney stone formation and potential strategies for prevention.
How similar studies have performed: While studies on oxalate metabolism exist, this specific approach using carbon 13 isotope tracing in healthy individuals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Sonia Fargue, M.D., Ph.D. — University of Alabama at Birmingham
- Study coordinator: Sonia Fargue, M.D., Ph.D.
- Email: kidneystone@uabmc.edu
- Phone: 205-975-6932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.