Clinical trial

Influence of Obesity on Endogenous Oxalate Synthesis

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03704350

Active, not recruitingNot applicableInterventional

What this study is about

There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis in both non-obese and obese non-kidney-stone forming adults. This study seeks to thusly increase the understanding of the relationships between obesity and endogenous oxalate synthesis to serve as a platform to develop novel therapies for stone prevention.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionKidney Stone

Full registry criteria

Inclusion Criteria: * Age 25-60 years * Body Mass Index (BMI) \<50 Exclusion Criteria: * history of kidney stones * history of diabetes, hepatic disease, renal disease including Chronic Kidney Disease (CKD), bowel disease or other endocrine disorders * pregnant or lactating women, or those with the intention to become pregnant in the near future * abnormal liver enzymes * hemoglobin A1C \> 6.5

Treatments and study arms

controlled diet

Dietary Supplement

Participants will consume a diet that is controlled in its daily contents of oxalate, calcium, vitamin C and sodium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements (vitamins, calcium or other minerals, herbal supplements, nutritional aids), to exercise strenuously, or to consume food or drink that is not provided to them as part of the controlled diet.

Primary outcomes

Urinary oxalate excretionBaseline through Day 12

Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States

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