High Salt Intake Unrelated to Obesity in Diabetes

Completed

• Conditions: Food Habits; Diabetes Mellitus, Type 1
• Interventions: Diagnostic Test: Urinary sodium concentrations

• Registration Number: NCT04256447
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-05-02
• Primary Completion: 2019-05-02
• Study Completion: 2019-06-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sixty-eight children and adolescents with type 1 diabetes	Urinary sodium concentrations	Sixty-eight children and adolescents aged between 4 and 18 years with type 1 diabetes. Patients with celiac disease, thyroid disease, other autoimmune diseases, concurrent illness, patients with diabetic nephropathy, other renal disease and in therapy with natriuretic drugs were excluded.

Primary Outcome Measures

Name	Time	Method
Urinary sodium concentrations	three days	Tested in three 24 h urine samples (immunochemical methodology )

Trial Locations

Locations (1)

Centro di Diabetologia Pediatrica "G.Stoppoloni"; 🇮🇹 Naples, Italy