Obesity and Endogenous Oxalate Synthesis

NCT03808090 | Completed Results

• 2 other identifiers: IRB130502007-OBE1K08DK115833-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

oxalate; obesity; kidney stones

Outcome Measures

Primary Outcomes (1)

• Urinary Oxalate Excretion

  Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day)

  3 days on the fixed diet

Secondary Outcomes (2)

• Urinary Glycolate Excretion

  3 days on fixed diet

• Urinary Creatinine Excretion

  3 days on the fixed diet

Study Arms (1)

Normal Individuals

EXPERIMENTAL

Normal individuals: no prior history of kidney stones

Dietary Supplement: Normal Individuals

Interventions

Normal Individuals DIETARY_SUPPLEMENT

Controlled Dietary phase: Low oxalate fixed diet 4 days of fixed normal calorie diet with low oxalate (\< 60 mg/day), normal calcium (800-1200 mg/day)

Normal Individuals

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-70 yrs Body Mass Index \> 18.5 kg/m2 Normal fasting serum electrolytes on comprehensive metabolic profile Willing to ingest fixed diets

You may not qualify if:

• Chronic Kidney Disease, estimated glomerular filtration rate \< 60 ml/mn/1.73m2 Primary hyperoxaluria Liver, endocrine or renal diseases or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion Pregnancy or breast-feeding Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus Active malignancy or treatment for malignancy within 12 months prior to screening Utilization of immunosuppressive medication Uncontrolled Hypertension or diabetes

Sponsors & Collaborators

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

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Obesity; Kidney Calculi

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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

Results Point of Contact

• Title: Dr Kyle Wood
• Organization: University of Alabama at Birmingham

kylewood@uabmc.edu

205-996-2295

Study Officials

• Kyle D Wood, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: January 17, 2019
• Study Start: January 1, 2013
• Primary Completion: July 1, 2023
• Study Completion: July 31, 2024
• Last Updated: September 19, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)