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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Kidney Stones Behavioral: Hypocaloric diet Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Urinary lithogenic factors variation [ Time Frame: 3 months ]
    serum and 24h urine test as before the diet.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02690662


Contacts
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Contact: Alexandre Danilovic, MD 5511 26618080 alexandre.danilovic@hc.fm.usp.br

Locations
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Brazil
University of Sao Paulo General Hospital Recruiting
Sao Paulo, Brazil
Contact: Alexandre Danilovic, MD    55-11-26618080    alexandre.danilovic@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Alexandre Danilovic, MD University of Sao Paulo General Hospital
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02690662    
Other Study ID Numbers: FAPESP 2015/04998-1
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Condensed data will be available for consultation
Keywords provided by University of Sao Paulo General Hospital:
Obesity
Kidney stones
Diet
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi