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

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02690662
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
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Study Details

Study Description

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
  • Behavioral: Hypocaloric diet
N/A

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.

Study Design

Study Type:
Interventional
Actual 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 :
Feb 1, 2016
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Urinary lithogenic factors variation [3 months]

    serum and 24h urine test as before the diet.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Sao Paulo General Hospital Sao Paulo Brazil

Sponsors and Collaborators

  • University of Sao Paulo General Hospital
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Alexandre Danilovic, MD, University of Sao Paulo General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02690662
Other Study ID Numbers:
  • FAPESP 2015/04998-1
First Posted:
Feb 24, 2016
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Sao Paulo General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021