Skip to main content
OpenTrials
Completed

NCT Number: NCT04256447

High Salt Intake Unrelated to Obesity in Diabetes

People around the world are consuming much more sodium than is physiologically necessary. A number of studies suggest that dietary sodium intake is related to weight gain. The aim of our study was to evaluate in a population of children and adolescents with type 1 diabetes mellitus, possible correlations between the urinary sodium excretion (UNa24h), indirect marker of sodium intake, and both duration of diabetes and BMI z-score(Body Mass Index). Moreover, we also evaluated the correlation between UNa24h and duration of diabetes according with the presence/absence of overweight/obesity.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Diabetologia Pediatrica "G.Stoppoloni"

Naples, 80100, Italy

About this study

Elevated sodium intake has been associated with hypertension, cardiovascular diseases and stroke, and decreasing sodium intake may reduce blood pressure and the risk of cardiovascular diseases (CVDs), leading cause of death in the world.

Recent data on sodium intake show that populations around the world are consuming much more sodium than is physiologically necessary.

Studies in children have reported positive associations between sodium intake and adiposity.

The aim of our study was to evaluate in a population of children and adolescents with type 1 diabetes mellitus, possible correlations between the urinary sodium excretion (UNa24h), indirect marker of sodium intake, and both duration of diabetes and BMI z-score. Moreover we also evaluated the correlation between UNa24h and duration of diabetes according with the presence/absence of overweight/obesity.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes Mellitus

Exclusion criteria

  • Patients with celiac disease, thyroid disease, other autoimmune diseases, concurrent illness, patients with diabetic nephropathy, other renal disease and in therapy with natriuretic drugs

Treatment and study plan

Urinary sodium concentrations

Diagnostic Test

The urinary sodium excretion was measured using an immunochemical methodology

Primary outcomes

  1. Urinary sodium concentrations

    Time frame: three days

    Tested in three 24 h urine samples (immunochemical methodology )

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

High Dietary Salt Intake in Pediatric Patients With Type 1 Diabetes Mellitus Not Related to Overweight and Obesity

Acronym: Diasalt

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.