Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02690662 |
| Other study ID # |
FAPESP 2015/04998-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2016 |
| Est. completion date |
May 2018 |
Study information
| Verified date |
October 2016 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to evaluate the influence of low-calorie diet on serum and
urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic
abnormalities.
Description:
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.
