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Trial record 87 of 95 for:    Recruiting, Not yet recruiting, Available Studies | diabetes | NIDDK | ( Map: United States )

Obesity and Endogenous Oxalate Synthesis

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ClinicalTrials.gov Identifier: NCT03808090
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kyle D. Wood, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Kidney Stone Other: Normal Individuals Other: Calcium Oxalate Kidney Stone Formers Other: Type 2 Diabetes Other: Type 2 diabetic kidney stone formers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Obesity and Endogenous Oxalate Synthesis
Actual Study Start Date : January 1, 2013
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Urinary oxalate excretion [ Time Frame: Baseline through 2 months ]
    Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808090


Contacts
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Contact: Billy Tingle, RN 205-934-3671 billy@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Billy Tingle, RN    205-934-3671    billy@uab.edu   
Principal Investigator: Kyle D Wood, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kyle D Wood, MD University of Alabama at Birmingham

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Responsible Party: Kyle D. Wood, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03808090     History of Changes
Other Study ID Numbers: IRB-130502007
1K08DK115833-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kyle D. Wood, University of Alabama at Birmingham:
oxalate
obesity
kidney stones
diabetes

Additional relevant MeSH terms:
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Obesity
Kidney Calculi
Nephrolithiasis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents