- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04256447
High Salt Intake Unrelated to Obesity in Diabetes (Diasalt)
High Dietary Salt Intake in Pediatric Patients With Type 1 Diabetes Mellitus Not Related to Overweight and Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Naples, Italy, 80100
- Centro di Diabetologia Pediatrica "G.Stoppoloni"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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The urinary sodium excretion was measured using an immunochemical methodology
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary sodium concentrations
Time Frame: three days
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Tested in three 24 h urine samples (immunochemical methodology )
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three days
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Collaborators and Investigators
Investigators
- Principal Investigator: Angela Zanfardino, MD, University of Campania "Luigi Vanvitelli"
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diasalt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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