Diabetes Mellitus, Type 1DiasaltNCT04256447
High Salt Intake Unrelated to Obesity in Diabetes
An observational study of Diabetes Mellitus, Type 1 and Food Habits, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Food Habits
- What is being tested?
- Urinary sodium concentrations
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Child, Adult
Study population: Children and adolescents affected by type 1 diabetes mellitus
Who may be able to join
- Type 1 Diabetes Mellitus
Who cannot join
- Patients with celiac disease, thyroid disease, other autoimmune diseases, concurrent illness, patients with diabetic nephropathy, other renal disease and in therapy with natriuretic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Dietary Salt Intake in Pediatric Patients With Type 1 Diabetes Mellitus Not Related to Overweight and Obesity
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.
- Conditions
- Diabetes Mellitus, Type 1, Food Habits
- Being tested
- Urinary sodium concentrations
- Medical subject headings
- Diabetes Mellitus, Type 1, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary sodium concentrationsDiagnostic test
The urinary sodium excretion was measured using an immunochemical methodology
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Urinary sodium concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sodium concentrations
Tested in three 24 h urine samples (immunochemical methodology )
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start2 May 2018
- Primary completion2 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Zanfardino, University of Campania Luigi Vanvitelli
- Investigators
- Angela Zanfardino, MD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256447
- Sponsor's protocol ID
- Diasalt
- Acronym
- Diasalt
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25853242Lucko 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 30101426Geserick 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dietary Salt Intake in Pediatric Patients With Type 1 Diabetes Mellitus Not Related to Overweight and Obesity
- ClinicalTrials.gov ID
- NCT04256447
- Acronym / sponsor ID
- Diasalt / Diasalt
- Conditions
- Diabetes Mellitus, Type 1, Food Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sixty-eight children and adolescents with type 1 diabetes | – | Diagnostic Test: Urinary sodium concentrationsSixty-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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and adolescents affected by type 1 diabetes mellitus
Key inclusion criteria (1 listed)
- Type 1 Diabetes Mellitus
Key exclusion criteria (1 listed)
- Patients with celiac disease, thyroid disease, other autoimmune diseases, concurrent illness, patients with diabetic nephropathy, other renal disease and in therapy with natriuretic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary sodium concentrationsThe urinary sodium excretion was measured using an immunochemical methodology | Diagnostic test | Sixty-eight children and adolescents with type 1 diabetes |
Primary outcome
Urinary sodium concentrations
Time frame: three days
Tested in three 24 h urine samples (immunochemical methodology )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Results publication: PubMed 25853242Campanozzi 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.
- Results publication: PubMed 30101426Lucko 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.
- Results publication: PubMed 30281992Geserick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Zanfardino, MD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Food Habits, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary sodium concentrations (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256447, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.