- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633811
Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone Formers
March 5, 2024 updated by: Dean Assimos, MD, University of Alabama at Birmingham
Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone
This protocol seeks to determine if weight reduction with the Optifast VLCD program leads to reduced contribution of endogenous oxalate synthesis to the urinary oxalate pool in obese calcium oxalate stone formers.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
- Dietary supplement: Low Oxalate Diet before Weight Loss
- Dietary supplement: Oral load of oxalate and sucralose before Weight Loss
- Dietary supplement: Optifast VLCD Program
- Dietary supplement: Optifast VLCD Transition Phase
- Dietary supplement: Low Oxalate Diet after Weight Loss
- Dietary supplement: Oral load of oxalate and sucralose after Weight Loss
Detailed Description
Obese adults (≥19 and ≤ 65 years) with a history of calcium oxalate kidney stone disease will be recruited at both University of Alabama at Birmingham (UAB) and University of Texas South Western (UTSW).
Following consent, subjects will complete a screening phase, which includes (1) a meeting with a dietitian to ensure willingness to consume controlled ultra-low oxalate diets and determine anthropometric measurements and blood pressure, (2) collection of fasted blood and 2 x 24-hour urine specimens on self-choice diets to determine general health status and urinary chemistries, respectively, (3) completion of a 7-day run-in diet that includes the use of one serving of an Optifast meal daily to assess tolerance to Optifast VLCD® products.
Participants will then consume an eucaloric, ultra-low oxalate controlled diet for 6 days.
The controlled dietary phase involves 2 days of dietary equilibration, followed by 2 x 24-hour urine collections, and on the 5th day a dietary oxalate/sucralose oral load.
Following the dietary oxalate/sucralose oral load, subjects will have blood collected every 30 minutes and collect 1-hour urines.
Participants will then go on an intensive 14-week Optifast VLCD® Program to induce weight loss.
At the end of this Optifast VLCD® Program participants will again perform the low oxalate controlled diet and dietary/sucralose oral load study.
A total of 40 adult obese calcium oxalate kidney stone formers (20 male and 20 female) will be enrolled (20 at UAB and 20 at UTSW).
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jane Vines, MPH
- Phone Number: 205-224-7324
- Email: kidneystoneresearch@uabmc.edu
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35243
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Jane Vines, MPH
- Phone Number: 205-224-7324
- Email: kidneystoneresearch@uabmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- First time or recurrent calcium oxalate stone formers defined as composition of most recent stone >50% calcium oxalate without uric acid component
- Last stone passage or removal greater than 3 months prior to screening
- Body Mass Index (BMI) >35 kg/m2
- Able to provide consent
- Hemoglobin A1C <6.5%
- Normal fasting blood CMP: Normal serum Na, K, Cl, CO2, Calcium, Albumin, AST, ALT <2 times upper limit of normal, Glucose <126 mg/dl, eGFR >60 ml/min/1.73 m2.
- 24-hour urine collection with creatinine within 20% of gender appropriate (mg creat/kg body weight) and consistent between collections (within 20% of each other)
- Willing to ingest menus prepared at the University of Alabama and University of Texas Southwestern Clinical Research Units
- Willing to consume the Optifast VLCD diet
- Willing to ingest menus prepared in Metabolic kitchen. No food allergies or intolerance to any of the foods in study menus. Substitutions for lactose intolerance will be made.
- Willing to avoid vigorous exercise during eucaloric, low-oxalate dietary phase
- Willing to stop use of weight-loss medications
- Willing to stop for 14 days before and during study: medications for stone prevention including diuretics, potassium citrate, allopurinol, febuxostat, and calcium, nutritional, or herbal supplements
- Those with controlled hypertension (systolic blood pressure <160 mmHg, diastolic <90 mmHg) will be included.
- Those without severe dyslipidemia (LDL <200 mg/dL, HDL >30 mg/dL, and triglycerides <250 mg/dL) will be included. Treated and controlled dyslipidemia is accepted
- Smoking/chewing tobacco/vaping will be allowed
Exclusion Criteria:
- Renal colic or past stone surgery in the past 3 months
- Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73m2
- History of type 2 diabetes or screening hgb A1c greater than or equal to 6.5%
- Alcohol or drug abuse. Alcohol consumption >12 units per week and/or unwillingness to abstain from alcohol consumption 2 days before and during the study.
- Mental/medical condition likely to impede study completion
- Current/planned pregnancy or breastfeeding in coming 6 months, unwillingness to use effective method of birth control during the study for individuals of childbearing potential.
- Planned vacation in coming 4 months
- Febrile illness including flu/common cold/COVID-19 within 21 days of study start
- Primary or enteric hyperoxaluria
- Gastrointestinal disorder or surgery that impacts oxalate transport
- Cirrhosis, pancreatic or biliary disorder, porphyria, gout
- Malignancy treated within the past 12 months
- Nephrotic syndrome, neurogenic bladder, urinary diversion
- History of primary hyperparathyroidism, cystinuria, renal tubular acidosis, sarcoidosis, cystic fibrosis
- Uncontrolled hypertension, myocardial infarction in past 6 months, unstable angina, congestive heart failure
- Medications: Topiramate, acetazolamide, zonisamide, diuretics, SGLT2-inhibitors, immunosuppressants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Controlled Diet and Weight Loss Program
Subjects will consume a low oxalate diet with blood and urine collections to establish baseline levels before undergoing a weight loss program with Optifast VLCD products.
After completing the weight loss program, subjects will once again consume a low oxalate diet with blood and urine collections to observe any changes that may have occurred due to the weight loss.
|
Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 6 days.
2 x 24 hour urines will be collected on days 3 and 4.
Subjects will ingest 100mg carbon-13 oxalate, and 2 grams of sucralose on day 5 of the 6-day low oxalate diet phase.
Following the oral load, blood and urine will be collected every 30 minutes and hourly, respectively
Subjects will go on a 10-week Intestive level Optifast VLCD weight loss program
After completion of the 10-week Optifast VLCD Program, subjects will be weaned off the Optifast products for 4 weeks.
Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 11 days and collect 2 x 24 hour urines on days 8 and 9
Subjects will ingest 100mg carbon-13 oxalate, and 2 grams of sucralose on day 10 of the 11-day low oxalate diet phase.
Following the oral load, blood and urine will be collected every 30 minutes and hourly, respectively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of 24 hour urinary oxalate excretion
Time Frame: 4 days
|
Subjects will ingest a controlled diet low in oxalate and collect 2 x 24-hour urines before and after the Optifast VLCD Program.
The utilization of a low oxalate diet allows assessment of the change in contribution of endogenous oxalate synthesis to the urinary oxalate pool.
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4 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dean Assimos, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2021
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
November 11, 2020
First Submitted That Met QC Criteria
November 11, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Body Weight
- Pathological Conditions, Anatomical
- Body Weight Changes
- Urolithiasis
- Urinary Calculi
- Calculi
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Weight Loss
- Kidney Calculi
- Nephrolithiasis
Other Study ID Numbers
- IRB-300006133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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