Type 1 Diabetes MellitusBiodaNCT03547440
T1DM Clinical Onset and Progression in Paediatric Population
An observational study of Type 1 Diabetes Mellitus, run by University of Turin, Italy at 3 sites in Italy.
Trial summary
Diabetes Mellitus Type I is the chronic metabolic disease of childhood with the highest incidence in developed countries. Over the past 10 years the incidence of diabetes has been increased especially in immigrants children. Read more about this study
- Who is it for?
- Ages Up to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 94 participants
- Where
- 3 sitesItaly
- Study dates
- 18 Mar 2015to 18 Sep 2018
- How long will I take part?
- 18 Months
- 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 Up to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children living in the Piedmont region. Primary care clinic of Torino and Novara (diabetologia for cases and orthopedia and general population for controls)
Who may be able to join
- Cases migrants : T1DM's recent diagnosis
- Italian cases : comparable to individual characteristics, living area, mainly age and gender
- Controls: healthy children (two control comparable for each case)
Who cannot join
- Children with parents of mixed origin
- Children with chronic gastrointestinal disorders (such as irritable bowel syndrome) or other relevant metabolic or systemic co-morbility
- Children who used antibiotics or with diarrhea in the last 15 days
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Pediatric Clinic - Hospital "Maggiore della Carità" of Novara
Novara
Dept. of Public Health and Pediatrics
Torino, 10126
Dep. of Medicine Science
Turin
About this study
Official title: Determinants of Type 1 Diabetes (T1DM) Clinical Onset and Progression in Paediatric Immigrant Population
Diabetes Mellitus Type I is the chronic metabolic disease of childhood with the highest incidence in developed countries. Over the past 10 years the incidence of diabetes has been increased especially in immigrants children. The objective of the investigator's project is to evaluate factors that influence the T1DM course in immigrant and Italian children through an analysis of the relationship between socio-cultural determinants, lifestyles and metabolic control. The study population will consist of 100 children with first diagnosis of T1DM divided into two cohorts (Italian and immigrant children). The project consists in a follow-up of 18 months from first visit and will include laboratory tests, two questionnaires and determination of a microbiological indicator of the microbiota and levels of 25-hydroxyvitamin D. The research hypothesis is that the two groups of study population show a different metabolic control of diabetes due to differences in access to care, compliance to therapy and type of nutrition.
Read the detailed description
Over the past ten years a contribution to the increasing incidence of T1DM is derived from children of foreign origin. As many studies confirmed environmental factors are involved in the onset and development of T1DM: type of nutrition, infections, perinatal events, characteristics of the microbial flora, 25-hydroxyvitamin D levels and early exposure to certain foods. Recent research has disclosed a tight connection between gut microbes, host metabolism and utilization and storage of energy. For this reason the microbiota could be implicated also into the diabetes ongoing. Methanobrevibacter smithii is the dominant methanogen in both the distal colon of individuals in health and disease. Some studies reported that immigrant children have a less efficient metabolic control in comparison to age-matched Italian children, thus identifying the different ethnic background as a risk factor for quality of life: a younger age at T1DM diagnosis is frequently observed in immigrant children, which may have also an increased risk of nutritional problems related to dietary habits, social disadvantage and poverty.
The project will make a comparative assessment in the two populations (italian and immigrant children). The research hypothesis is that the two analysed groups show a different metabolic control of diabetes due to differences in access to care, in compliance to therapy and in type of nutrition.
Specific Aim:
- Estimate any discrepancies in the course of T1DM among the two populations by assessing the modality of hospital admission (ordinary or emergency) and the structures involved.
- Evaluate the quantity range of a microbiological indicator of intestinal microbial flora, (Methanobrevibacter smithii) determined by molecular techniques on stool samples and the levels of 25-hydroxyvitamin D in serum. That difference will be evaluated on immigrants and non-immigrants diabetic children and on a control group of healthy children.
- Estimate of the main outcomes of two T1DM populations (glycated hemoglobin, number of hospitalizations for acute events with the calculation of hospital days per year, U insulin / kg / day, dose of C-peptide as an expression of residual pancreatic function) and their compliance to therapy and prescriptions (frequency of tests and visits, adherence to insulin therapy, dietary lifestyles).
Case-control at the onset of Italian T1DM versus Immigrant T1DM by assessing hospital admissions [Aim 1]
Origin-stratified case control [Case (T1DM) vs double control (healthy), italian and immigrant: evaluation microbiota/metabolic profile, vit D] [Aim 2]
Prospective cohort study (TDM1 italian vs TDM1 immigrant: evaluation of the impact of social and health-related factors) [Aim 3]
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, immigrant, microbiota, bioindicator, Methanobrevibacter smithii
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes mellitus | Children with type 1 diabetes mellitus, usually not obese, with diabetic ketoacidosis. They could be with or without stationary metabolic profile. They are recruited at the onset of the T1DM into the Torino and Novara Pediatric Hospitals and then they are divided in relation to the ethnicity. | |
| Control healthy | Healthy children without relevant metabolic or systemic co-morbility. They are recruited from orthopedy department of the Torino and Novara Pediatric hospitals and then they are divided in relation to the ethnicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic control
The blood pH of the patients are measured at the onset to define ketoacidosis following normal standard hospital procedure.
Measured: at onset
Secondary outcomes (7)
Body mass index
calculated as (weight (kg))/(height (meters))exp2
Measured: at onset
Glycated hemoglobin
in % and as mmol/mol
Measured: at onset
Diet behaviour
The 24h-recall technique reconstructed meals and food intake on a recent "typical" day, estimating, under a bromatology point of vie, inputs according to food composition database for epidemiological studies in Italy (BDA)
Measured: at onset
vitamin D
evaluated from serum sample as 25-hydroxyvitamin D (ng/ml)
Measured: at the onset
Microbiome bioindicators
The Denaturing Gradient Gel Electrophoresis profile was evaluated for each patients starting from the stool sample. Shannon index is calculated (theory range from 0 to infinite; in literature from 0.1 to 4)
Measured: at onset
Methanobrevibacter smithii
Starting from the stool DNA extracted, following bioindicator measured by quantitative Real Time Polymerase Chain Reaction: Methanobrevibacter smithii (num gene copies - both as 16S ribosomal RNA gene and nifH gene /g stool)
Measured: at onset
Akkermansia muciniphila quantification in stool
Starting from the stool DNA extracted, following bioindicator measured by quantitative Real Time Polymerase Chain Reaction : Akkermansia muciniphila (num copies 16SrDNA /g stool)
Measured: at onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start18 Mar 2015
- Primary completion30 Jun 2017
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita, A.O.U. Città della Salute e della Scienza
- Responsible party
- Principal investigator, Deborah Traversi, University of Turin, Italy
- Investigators
- Roberta T Siliquini, Prof., Principal investigator, University of Turin - Hygiene and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547440
- Sponsor's protocol ID
- G12114000080001
- Other IDs
- RF-2011-02350617
- Acronym
- Bioda
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2017
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Type 1 Diabetes (T1DM) Clinical Onset and Progression in Paediatric Immigrant Population
- ClinicalTrials.gov ID
- NCT03547440
- Acronym / sponsor ID
- Bioda / G12114000080001
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, immigrant, microbiota, bioindicator, Methanobrevibacter smithii
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita, A.O.U. Città della Salute e della Scienza
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 6 Jun 2018 (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.
Diabetes Mellitus Type I is the chronic metabolic disease of childhood with the highest incidence in developed countries. Over the past 10 years the incidence of diabetes has been increased especially in immigrants children. The objective of the investigator's project is to evaluate factors that influence the T1DM course in immigrant and Italian children through an analysis of the relationship between socio-cultural determinants, lifestyles and metabolic control. The study population will consist of 100 children with first diagnosis of T1DM divided into two cohorts (Italian and immigrant children). The project consists in a follow-up of 18 months from first visit and will include laboratory tests, two questionnaires and determination of a microbiological indicator of the microbiota and levels of 25-hydroxyvitamin D. The research hypothesis is that the two groups of study population show a different metabolic control of diabetes due to differences in access to care, compliance to therapy and type of nutrition.
Detailed description
Over the past ten years a contribution to the increasing incidence of T1DM is derived from children of foreign origin. As many studies confirmed environmental factors are involved in the onset and development of T1DM: type of nutrition, infections, perinatal events, characteristics of the microbial flora, 25-hydroxyvitamin D levels and early exposure to certain foods. Recent research has disclosed a tight connection between gut microbes, host metabolism and utilization and storage of energy. For this reason the microbiota could be implicated also into the diabetes ongoing. Methanobrevibacter smithii is the dominant methanogen in both the distal colon of individuals in health and disease. Some studies reported that immigrant children have a less efficient metabolic control in comparison to age-matched Italian children, thus identifying the different ethnic background as a risk factor for quality of life: a younger age at T1DM diagnosis is frequently observed in immigrant children, which may have also an increased risk of nutritional problems related to dietary habits, social disadvantage and poverty.
The project will make a comparative assessment in the two populations (italian and immigrant children). The research hypothesis is that the two analysed groups show a different metabolic control of diabetes due to differences in access to care, in compliance to therapy and in type of nutrition.
Specific Aim:
- Estimate any discrepancies in the course of T1DM among the two populations by assessing the modality of hospital admission (ordinary or emergency) and the structures involved.
- Evaluate the quantity range of a microbiological indicator of intestinal microbial flora, (Methanobrevibacter smithii) determined by molecular techniques on stool samples and the levels of 25-hydroxyvitamin D in serum. That difference will be evaluated on immigrants and non-immigrants diabetic children and on a control group of healthy children.
- Estimate of the main outcomes of two T1DM populations (glycated hemoglobin, number of hospitalizations for acute events with the calculation of hospital days per year, U insulin / kg / day, dose of C-peptide as an expression of residual pancreatic function) and their compliance to therapy and prescriptions (frequency of tests and visits, adherence to insulin therapy, dietary lifestyles).
Case-control at the onset of Italian T1DM versus Immigrant T1DM by assessing hospital admissions [Aim 1]
Origin-stratified case control [Case (T1DM) vs double control (healthy), italian and immigrant: evaluation microbiota/metabolic profile, vit D] [Aim 2]
Prospective cohort study (TDM1 italian vs TDM1 immigrant: evaluation of the impact of social and health-related factors) [Aim 3]
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes mellitus | – | –Children with type 1 diabetes mellitus, usually not obese, with diabetic ketoacidosis. They could be with or without stationary metabolic profile. They are recruited at the onset of the T1DM into the Torino and Novara Pediatric Hospitals and then they are divided in relation to the ethnicity. |
| Control healthy | – | –Healthy children without relevant metabolic or systemic co-morbility. They are recruited from orthopedy department of the Torino and Novara Pediatric hospitals and then they are divided in relation to the ethnicity |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children living in the Piedmont region. Primary care clinic of Torino and Novara (diabetologia for cases and orthopedia and general population for controls)
Key inclusion criteria (3 listed)
- Cases migrants : T1DM's recent diagnosis
- Italian cases : comparable to individual characteristics, living area, mainly age and gender
- Controls: healthy children (two control comparable for each case)
Key exclusion criteria (3 listed)
- Children with parents of mixed origin
- Children with chronic gastrointestinal disorders (such as irritable bowel syndrome) or other relevant metabolic or systemic co-morbility
- Children who used antibiotics or with diarrhea in the last 15 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic control
Time frame: at onset
The blood pH of the patients are measured at the onset to define ketoacidosis following normal standard hospital procedure.
7 secondary outcomes
Body mass index
Time frame: at onset
Glycated hemoglobin
Time frame: at onset
Diet behaviour
Time frame: at onset
vitamin D
Time frame: at the onset
Microbiome bioindicators
Time frame: at onset
Methanobrevibacter smithii
Time frame: at onset
Akkermansia muciniphila quantification in stool
Time frame: at onset
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 4 Dec 2024.
- 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.
Roberta T Siliquini, Prof. principal investigator
University of Turin - Hygiene and Preventive Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by University of Turin, Italy at 3 sites 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 3 inclusion and 3 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 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Metabolic control (time frame: at onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2024.