Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones
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|ClinicalTrials.gov Identifier: NCT02690662|
Recruitment Status : Unknown
Verified October 2016 by University of Sao Paulo General Hospital.
Recruitment status was: Recruiting
First Posted : February 24, 2016
Last Update Posted : October 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity Kidney Stones||Behavioral: Hypocaloric diet||Not Applicable|
Objective: to evaluate the influence of low-calorie diet on serum and urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic abnormalities.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Obese with kidney stones
Hypocaloric diet for 3 months
Behavioral: Hypocaloric diet
recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day
- Urinary lithogenic factors variation [ Time Frame: 3 months ]serum and 24h urine test as before the diet.
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): NCT02690662
|Contact: Alexandre Danilovic, MD||5511 firstname.lastname@example.org|
|University of Sao Paulo General Hospital||Recruiting|
|Sao Paulo, Brazil|
|Contact: Alexandre Danilovic, MD 55-11-26618080 email@example.com|
|Principal Investigator:||Alexandre Danilovic, MD||University of Sao Paulo General Hospital|