Influence of Obesity on Endogenous Oxalate Synthesis

NCT03704350 | Active Not Recruiting

• 3 other identifiers: IRB-300002318-P20P20DK119788UAB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (1)

• Urinary oxalate excretion

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

  Baseline through Day 12

Study Arms (6)

20-24.9 BMI

ACTIVE COMPARATOR

Participants with a BMI that falls between 20 and 24.9 who will receive the controlled diet

Dietary Supplement: controlled diet

25-29.9 BMI

ACTIVE COMPARATOR

Participants with a BMI that falls between 25 and 29.9 who will receive the controlled diet

Dietary Supplement: controlled diet

30-34.9 BMI

ACTIVE COMPARATOR

Participants with a BMI that falls between 30 and 34.9 who will receive the controlled diet

Dietary Supplement: controlled diet

35-39.9 BMI

ACTIVE COMPARATOR

Participants with a BMI that falls between 35 and 39.9 who will receive the controlled diet

Dietary Supplement: controlled diet

40-44.9 BMI

ACTIVE COMPARATOR

Participants with a BMI that falls between 40 and 44.9 who will receive the controlled diet

Dietary Supplement: controlled diet

45-50 BMI

ACTIVE COMPARATOR

Participants with a BMI that falls between 45 and 50 who will receive the controlled diet.

Dietary Supplement: controlled diet

Interventions

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.

20-24.9 BMI; 25-29.9 BMI; 30-34.9 BMI; 35-39.9 BMI; 40-44.9 BMI; 45-50 BMI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-60 years
• Body Mass Index (BMI) \<50

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dean Assimos, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 12, 2018
• Study Start: May 24, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)