Clinical trial NCT03547440: T1DM Clinical Onset and Progression in Paediatric Population
Official title: Determinants of Type 1 Diabetes (T1DM) Clinical Onset and Progression in Paediatric Immigrant Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
immigrant
microbiota
bioindicator
Methanobrevibacter smithii
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria Maggiore della Carita
name: A.O.U. Città della Salute e della Scienza
First posted: 2018-06-06
Enrollment: 94
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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. 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:

1. 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.
2. 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.
3. 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) \[Aim 3\]

Eligibility criteria: Inclusion Criteria:

1. Cases migrants : T1DM's recent diagnosis
2. Italian cases : comparable to individual characteristics, living area, mainly age and gender
3. Controls: healthy children (two control comparable for each case)

Exclusion Criteria:

1. Children with parents of mixed origin
2. Children with chronic gastrointestinal disorders (such as irritable bowel syndrome) or other relevant metabolic or systemic co-morbility
3. Children who used antibiotics or with diarrhea in the last 15 days

Primary outcomes:
measure: Metabolic control
timeFrame: at onset
Secondary outcomes:
measure: Body mass index
timeFrame: at onset
measure: Glycated hemoglobin
timeFrame: at onset
measure: Diet behaviour
timeFrame: at onset
measure: vitamin D
timeFrame: at the onset
measure: Microbiome bioindicators
timeFrame: at onset
measure: Methanobrevibacter smithii
timeFrame: at onset
measure: Akkermansia muciniphila quantification in stool
timeFrame: at onset
Other outcomes:
measure: Metabolic control 2
timeFrame: at onset
Locations:
city: Novara
country: Italy
facility: Pediatric Clinic - Hospital "Maggiore della Carità" of Novara
city: Torino
country: Italy
facility: Dept. of Public Health and Pediatrics
city: Turin
country: Italy
facility: Dep. of Medicine Science
Study officials:
affiliation: University of Turin - Hygiene and Preventive Medicine
name: Roberta T Siliquini, Prof.
role: PRINCIPAL_INVESTIGATOR
References: