Influence of Obesity on Endogenous Oxalate Synthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-24

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Calcium oxalate stone disease results in billions of dollars in healthcare costs per year, creates large economic losses due to decreased work productivity, and produces significant pain and suffering in affected individuals impacting quality of life. Almost 9% of the population in the United States may now experience a stone event at least once in their lifetime and that figure is increasing. Although stone removing treatments have advanced in the last few decades with a variety of minimally invasive procedures such as shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy, our knowledge of how stones form and how to prevent them has not kept pace. Approximately 70-80% of the stones formed contain oxalate. Oxalate is an end product of metabolism and an ubiquitous element of human diets. Small increases in urinary oxalate can increase calcium oxalate crystal formation and thus stone disease. Urinary oxalate levels are affected by both dietary and endogenous components, complicating the discrimination between the two sources. Multiple epidemiological and clinical studies have demonstrated a link between body mass index (BMI) and kidney stone disease and also an increased urinary oxalate excretion.

The interpretation of studies suggesting a link between obesity and the amount of urinary oxalate excreted is confounded by the failure in most studies to use diets controlled in calcium and oxalate. Adult humans without a history of kidney stones will be placed on controlled low oxalate diets to estimate the contribution of endogenous oxalate synthesis to the urinary oxalate pool. In addition, oral doses of 13C2-glycolate and 13C6- vitamin C will be used to determine their conversions to 13C2-oxalate and provide an index of endogenous oxalate production. Body morphometric indices, markers of oxidative stress, and insulin resistance will be assessed in these subjects.They will also be evaluated with DXA and MRI to define body fat content and distribution.

Conditions

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Kidney Stone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Intervention Type 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.

Interventions

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controlled diet

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Dean Assimos, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dean Assimos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sonia Fargue, MD PhD

Role: CONTACT

Phone: 205-934-0169

Email: [email protected]

Facility Contacts

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Sonia Fargue, MD

Role: primary

Other Identifiers

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P20DK119788

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300002318-P20

Identifier Type: -

Identifier Source: org_study_id

Influence of Obesity on Endogenous Oxalate Synthesis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

20-24.9 BMI

controlled diet

25-29.9 BMI

controlled diet

30-34.9 BMI

controlled diet

35-39.9 BMI

controlled diet

40-44.9 BMI

controlled diet

45-50 BMI

controlled diet

Interventions

controlled diet

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

University of Alabama at Birmingham

Responsible Party

Dean Assimos, MD

Principal Investigators

Dean Assimos, MD

Locations

University of Alabama at Birmingham

Countries

Central Contacts

Sonia Fargue, MD PhD

Facility Contacts

Sonia Fargue, MD

Other Identifiers

P20DK119788

UAB

IRB-300002318-P20