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NCT Number: NCT02690662

Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index above 30 kg/m2 and urinary calculi on tomography and lithogenic metabolic abnormalities.

Exclusion criteria

  • psychiatric diagnoses other than depression
  • inability to attend to clinical follow-up
  • nephrocalcinosis
  • urinary tract infection
  • cystinuria
  • previous surgeries to treat obesity

Treatment and study plan

Hypocaloric diet

Behavioral

recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day

Primary outcomes

  1. Urinary lithogenic factors variation

    Time frame: 3 months

    serum and 24h urine test as before the diet.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2016
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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