Clinical trial NCT04256447: High Salt Intake Unrelated to Obesity in Diabetes
Official title: High Dietary Salt Intake in Pediatric Patients With Type 1 Diabetes Mellitus Not Related to Overweight and Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Food Habits
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 68
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents affected by type 1 diabetes mellitus

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary sodium concentrations
timeFrame: three days
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Centro di Diabetologia Pediatrica "G.Stoppoloni"
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Angela Zanfardino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.