- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02690662
Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sao Paulo, Brazil
- University of Sao Paulo General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Obese with kidney stones
Hypocaloric diet for 3 months
|
recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary lithogenic factors variation
Time Frame: 3 months
|
serum and 24h urine test as before the diet.
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alexandre Danilovic, MD, University of Sao Paulo General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAPESP 2015/04998-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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