NCT02690662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

February 15, 2016

Last Update Submit

September 28, 2021

Conditions

ObesityKidney Stones

Keywords

ObesityKidney stonesDiet

Outcome Measures

Primary Outcomes (1)

  • Urinary lithogenic factors variation

    serum and 24h urine test as before the diet.

    3 months

Study Arms (1)

Obese with kidney stones

EXPERIMENTAL

Hypocaloric diet for 3 months

Behavioral: Hypocaloric diet

Interventions

Hypocaloric dietBEHAVIORAL

recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day

Obese with kidney stones

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index above 30 kg/m2 and urinary calculi on tomography and lithogenic metabolic abnormalities.

You may not qualify if:

  • psychiatric diagnoses other than depression
  • inability to attend to clinical follow-up
  • nephrocalcinosis
  • urinary tract infection
  • cystinuria
  • previous surgeries to treat obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, Brazil

Location

MeSH Terms

Conditions

ObesityKidney Calculi

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, Anatomical

Study Officials

  • Alexandre Danilovic, MD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 24, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 6, 2021

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Condensed data will be available for consultation

Locations

BR(1)