Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones
NCT ID: NCT02690662
Last Updated: 2021-10-06
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-02-29
2018-05-31
Brief Summary
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Detailed Description
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Method: prospective study of 50 patients, aged over 18 years, with a body mass index above 30 kg/m2, urinary calculi and lithogenic metabolic abnormalities. Will be excluded from the study patients with psychiatric diagnoses other than depression, patients with inability to attend to clinical follow-up, patients with nephrocalcinosis, patients with urinary tract infection, patients with cystinuria and patients subjected to previous surgeries to treat obesity. Each patient will be evaluated monthly on the same day by urologist and nutritionist. On the first evaluation, will be done anamnesis, anthropometric measurements of weight, height, waist, bioimpedance and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uric acid, and PTH, pH venous blood, urine tests type I, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uric acid, cystine and computed tomography for evaluation of urinary calculus. In the second evaluation, 30 days after, anthropometric measures will be repeated, bioimpedance and nutritional assessment will be made with recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uric acid, and PTH, pH venous blood, urine tests type I, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uric acid, cystine. Patients will be monitored monthly for 3 months with anthropometric measurements, bioimpedance and strengthening of nutritional recommendations. By the end of the third month, patients will be submitted to two series of serum and urine tests as before the diet. The results of serum and urine tests from the beginning of dietary treatment will be compared to those of the end of the treatment with Student T test. P\<0.05 are considered significant.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Obese with kidney stones
Hypocaloric diet for 3 months
Hypocaloric diet
recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day
Interventions
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Hypocaloric diet
recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* inability to attend to clinical follow-up
* nephrocalcinosis
* urinary tract infection
* cystinuria
* previous surgeries to treat obesity
18 Years
60 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Alexandre Danilovic, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo General Hospital
Locations
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University of Sao Paulo General Hospital
São Paulo, , Brazil
Countries
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Other Identifiers
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FAPESP 2015/04998-1
Identifier Type: -
Identifier Source: org_study_id
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