Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04333745
• Collaborator: (none)
• Enrollment: 64
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 51
• Patients Per Site: 32
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The primary goals of this study are to determine the contribution of dietary oxalate absorption, renal oxalate handling, and endogenous oxalate synthesis to urinary oxalate excretion in normal Body Mass Index (BMI) and obese calcium oxalate kidney stone formers.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Other: Controlled Diet; Dietary Supplement: Carbon-13 Oxalate and Sucralose Ingestion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Controlled Dietary Study Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion.	Other: Controlled Diet; Participant will consume a controlled low oxalate diet for five days; Dietary Supplement: Carbon-13 Oxalate and Sucralose Ingestion; Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.

Outcome Measures

Primary Outcome Measures

1. Urinary Oxalate Excretion [Baseline through Day 5]

   Urinary oxalate excretion from urine samples will be measured as mg/day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Normal Body Mass Index (≥ 18.5 to < 25); Obese Body Mass Index (≥ 30 to ≤ 45)

• Able to provide informed consent

• Willingness to consume controlled diet

• Composition of most recent stone > 50% calcium oxalate, no uric acid component

• First time or recurrent calcium oxalate stone former

• 24-hour urine collections with creatinine values within 20% of appropriate ratio of creatinine (mg)/body weight (kg) for gender, and with creatinine values that are consistent between collections (within 20% of each other)

• Willingness to stop supplements [vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics] for 14 days before start and during study

• Willingness to not undertake vigorous exercise during the controlled dietary study

• Normal fasting blood Comprehensive Metabolic Panel

• Hemoglobin A1c < 6.5%

• No food allergies or intolerance to any of the food in study menus

• Permitted/willing to discontinue medications for kidney stone prevention, including thiazides, allopurinol, and febuxostat and citrate preparations, for 14 days before start and during the studies. They will be instructed to restart these medications at the conclusion of the study

Exclusion Criteria:

• Diabetes

• Abnormal fasting comprehensive metabolic panel (CMP)

• Hemoglobin A1c (HbA1c) result ≥ 6.5%

• Gout

• Estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2

• Primary hyperoxaluria

• Cystic fibrosis

• Cystinuria

• Uric acid stone former

• Utilization of immunosuppressive medication

• Nephrotic syndrome

• Enteric hyperoxaluria

• Gastrointestinal disorder that could impact oxalate transport

• Sarcoidosis

• Uncontrolled hypertension

• Renal tubular acidosis

• Primary hyperparathyroidism

• Liver disease

• Neurogenic bladder

• Urinary diversion

• Chronic diarrhea

• Bariatric surgery

• Active malignancy or treatment for malignancy within 12 months prior to screening

• Pregnancy

• Breast feeding/nursing

• Females of child bearing age who are not able to use an effective method of birth control during the study

• Mental/medical condition that is likely to impede successful study completion

• Illness including flu / common cold / fever 14 days before study and during study

• Diarrhea or other abnormal gastrointestinal event (e.g. abnormal bowel movements) 14 days before study or during study

• Antibiotic use within last 6 months (based on recommendations of the NIH Human Microbiome Project, Protocol A)

• Inability or unwillingness to undergo MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35243-3353
2	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Dean Assimos, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dean Assimos, MD, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04333745
• Other Study ID Numbers: IRB-300004693
• First Posted: Apr 3, 2020
• Last Update Posted: Oct 8, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dean Assimos, MD, Principal Investigator, University of Alabama at Birmingham: oxalate; kidney stone
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi

Study Results

No Results Posted as of Oct 8, 2021