Obesity and Endogenous Oxalate Synthesis

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Dietary Supplement: Normal Individuals

• Registration Number: NCT03808090
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The goal of this study is to determine if obesity is associated with increased endogenous oxalate synthesis as assessed by urinary oxalate excretion, which is a known risk factor for calcium oxalate kidney stones.

The study will recruit adult participants without history of kidney stones. Participants will

* Ingest fixed diets containing low amounts of oxalate for 4 days

* Collect 24-hr urine samples during the fixed diet

Detailed Description

In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, in individuals of varying body sizes without history of kidney stones. The 24-hr urinary oxalate excretion on such a low-oxalate normal calcium fixed diet is determined to be an appropriate surrogate for endogenous oxalate synthesis.

Screening phase. The study will enroll 60 individuals without history of kidney stones (30 males/30 females) at the University of Alabama at Birmingham (UAB).

Screening will include blood complete metabolic profile, 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements.

Dietary phase Participants will ingest a low-oxalate (\<60 mg/day), normal calcium (1000 mg/day) fixed diet for 4 consecutive days, collect three 24-hr urines after 1 day of dietary equilibration and have a fasted blood draw on day 5.

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Primary Completion: 2023-07-01
• Results First Submitted: 2024-06-28
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Results First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal Individuals	Normal Individuals	Normal individuals: no prior history of kidney stones

Primary Outcome Measures

Name	Time	Method
Urinary Oxalate Excretion	3 days on the fixed diet	Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day)

Secondary Outcome Measures

Name	Time	Method
Urinary Glycolate Excretion	3 days on fixed diet	mean of three 24-hr urinary glycolate collected on the fixed diet (mg/day)
Urinary Creatinine Excretion	3 days on the fixed diet	mean of there 24hr urinary creatinine excretion on the fixed diet ( g/day)

Trial Locations

Locations (1)

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