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CompletedNCT04256447DiasaltUpdated Feb 5, 2020

High Salt Intake Unrelated to Obesity in Diabetes

An observational study in Diabetes Mellitus, Type 1 and Food Habits, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by University of Campania Luigi Vanvitelli · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
68
Ages
4 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
  • Food Habits
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 68 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Children and adolescents affected by type 1 diabetes mellitus

Inclusion criteria

  • Type 1 Diabetes Mellitus

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
68 participants (actual)
Patient registry
No

Groups and cohorts

  • Sixty-eight children and adolescents with type 1 diabetes

    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.

    Diagnostic Test: Urinary sodium concentrations

Interventions

  • Diagnostic testUrinary sodium concentrations

    The urinary sodium excretion was measured using an immunochemical methodology

06

What researchers measure

Primary outcomes

  1. Urinary sodium concentrations

    Tested in three 24 h urine samples (immunochemical methodology )

    Time frame: three days

07

Study locations

1 site
  • Centro di Diabetologia Pediatrica "G.Stoppoloni"
    Naples, 80100, Italy
08

References and documents

Publications

  • Campanozzi A, Avallone S, Barbato A, Iacone R, Russo O, De Filippo G, D'Angelo G, Pensabene L, Malamisura B, Cecere G, Micillo M, Francavilla R, Tetro A, Lombardi G, Tonelli L, Castellucci G, Ferraro L, Di Biase R, Lezo A, Salvatore S, Paoletti S, Siani A, Galeone D, Strazzullo P; MINISAL-GIRCSI Program Study Group. High sodium and low potassium intake among Italian children: relationship with age, body mass and blood pressure. PLoS One. 2015 Apr 8;10(4):e0121183. doi: 10.1371/journal.pone.0121183. eCollection 2015. PubMed 25853242 ↗
  • Lucko AM, Doktorchik C, Woodward M, Cogswell M, Neal B, Rabi D, Anderson C, He FJ, MacGregor GA, L'Abbe M, Arcand J, Whelton PK, McLean R, Campbell NRC; TRUE Consortium. Percentage of ingested sodium excreted in 24-hour urine collections: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2018 Sep;20(9):1220-1229. doi: 10.1111/jch.13353. Epub 2018 Aug 12. No abstract available. PubMed 30101426 ↗
  • Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, Pfaffle R, Kiess W, Korner A. Acceleration of BMI in Early Childhood and Risk of Sustained Obesity. N Engl J Med. 2018 Oct 4;379(14):1303-1312. doi: 10.1056/NEJMoa1803527. PubMed 30281992 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04256447
Lead sponsor
University of Campania Luigi Vanvitelli
Responsible party
Angela Zanfardino (Medical Doctor, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
Feb 5, 2020
Start date
May 2, 2018
Primary completion
May 2, 2019
Completion
Jun 30, 2019
Last update
Feb 5, 2020

Study contacts

Angela Zanfardino, MD
principal investigator · University of Campania Luigi Vanvitelli

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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