Metabolic Assessment of Aging Men With Urinary Lithiasis

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01246531

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Urinary lithiasis is a common disease on young adults, but not so far on aging people. Nowadays, the investigators are seeing a gradative growth on men above sixty years old, mainly in industrialized countries. The purpose of this study is to investigate metabolic aspects of aging men with renal stones, towards blood tests, 24 hour-urinary samples, imagenological exams and bone densitometry. The investigators have made a case-control model.

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis and Aging Renal Calcul and Metabolic Diseases Urolithiasis and Osteoporosis

Detailed Description

Urolithiasis is a common disease, with an overall prevalence about 2% in the world. Accordingly growth of life expectancy, elderly people become more susceptible to present renal calculi.

The investigators have two purposes: (1) evaluate metabolic disturbances in aging men with urinary lithiasis, and (2) evaluate bone demineralization in aging men with renal calculi.

The investigators have made a case-control model. The case-group is compposed by men with more than fifty years-old who had their first lithiasic diagnosis (renal colic ou incidental finding) after that age. The control-group is compposed by men with more than fifty years-old who had never diagnosed with renal stones. So the investigators have excluded men with repetitive episodes of renal colic, that could be negatively influence the outcomes of aging factors on urinary lithiasis. All the people have to submitted to blood tests, 24-hour urinary samples, abdominal ultrassonography and abdominal X-ray (or abdominal CT, if necessary); and bone densitometry. The investigators hope to achieve reliable conclusions about urinary lithogenesis.

Blood tests: total calcium, ionized calcium, uric acid, phosphorus, creatinine, urea, testosterone and parathyroid hormone.

24-hour urinary sample(s): calcium, uric acid, creatinine, citrate, sodium, pH and volume. Patients of the case arm had to collect 6 24-hour urine samples, while the control arm had collected 3 24-hour urine samples.

Data were analyzed using the Fischer's exact, Chi-square and Mann-Whitney tests; a level of significance of 5% was adopted.

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Clinical Investigation of Aging Men With Renal Stones: The Role of Bone Demineralization (Metabolic and Hormonal Assessment)

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Urolithiasis Case arm: men above fifty years-old with urolithiasis
Control Control arm: men above fifty years-old without urolithiasis

Outcome Measures

Primary Outcome Measures

Hypocitraturia is the main metabolic disturbance in aging men with urinary lithiasis [Two years]
Aging men that had initiated their clinical signs or symptoms of urinary lithiasis above fifty years-old, presented hypocitraturia like the most common metabolic disturbance in 24-hour urine analysis. This finding had been different when we look for younger renal stones formers. In these, hypercalciuria is the main metabolic disturbance. Idiopathic hypercalciuria could affect men in a precocious phase of their lives, because of the genetic basis. However hypocitraturia could be related with acidified status, secondarily to alimentary habits, mainly excessive protein and sodium diarily intake.