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Purpose

The goal of this proposal is to determine the contribution and significance of obesity to urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful completion of the study will provide insight into the link between obesity and kidney stone disease and should identify future strategies to treat this disease.

Conditions

Eligibility

Eligible Ages
Between 19 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Body Mass Index (BMI) < 30 - Calcium oxalate stone formers with passage or removal of a kidney stone containing > 50% calcium oxalate - Type 2 Diabetics with fasting glucose > 126 mg/dL or hemoglobin A1c greater than or equal to 6.5%

Exclusion Criteria

  • Any disease that will affect the urinary excretion of oxalate, calcium or another ion that will compromise the interpretation of results. - Abnormal urine chemistries or blood metabolic profiles - A glomerular filtration rate (GFR) or estimated GFR < 60 mls/min - Pregnancy - Body Mass Index (BMI) > 32

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Normal Individuals 		Normal individuals: no prior history of KS, no obesity, no diabetes
  • Other: Normal Individuals
    Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
Experimental
Calcium Oxalate Kidney Stone Formers 		Those individuals that have a high propensity to form calcium oxalate kidney stones
  • Other: Calcium Oxalate Kidney Stone Formers
    Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
Experimental
Type 2 Diabetes 		Those individuals that have been diagnosed with type 2 diabetes
  • Other: Type 2 Diabetes
    Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
Experimental
Type 2 diabetic kidney stone formers 		Those individuals that have been diagnosed with type 2 diabetes and kidney stones.
  • Other: Type 2 diabetic kidney stone formers
    Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver

More Details

Status
Active, not recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.