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

Primary Purpose

Obesity, Kidney Stones

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hypocaloric diet
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Kidney stones, Diet

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obese with kidney stones

Arm Description

Hypocaloric diet for 3 months

Outcomes

Primary Outcome Measures

Urinary lithogenic factors variation
serum and 24h urine test as before the diet.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2016
Last Updated
September 28, 2021
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02690662
Brief Title
Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones
Official Title
Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Kidney Stones
Keywords
Obesity, Kidney stones, Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese with kidney stones
Arm Type
Experimental
Arm Description
Hypocaloric diet for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Hypocaloric diet
Intervention Description
recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day
Primary Outcome Measure Information:
Title
Urinary lithogenic factors variation
Description
serum and 24h urine test as before the diet.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Danilovic, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Condensed data will be available for consultation

Learn more about this trial

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

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