T1DM Clinical Onset and Progression in Paediatric Population

Type 1 Diabetes Mellitus Clinical Trial

— Bioda  

Official title:

Determinants of Type 1 Diabetes (T1DM) Clinical Onset and Progression in Paediatric Immigrant Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03547440
• Other study ID #: G12114000080001
• Secondary ID: RF-2011-02350617
• Status: Active, not recruiting
• Start date: March 18, 2015
• Est. completion date: September 18, 2018

Study information

• Verified date: June 2018
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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]

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: September 18, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Italy	Pediatric Clinic - Hospital "Maggiore della Carità" of Novara	Novara
Italy	Dept. of Public Health and Pediatrics	Torino
Italy	Dep. of Medicine Science	Turin

Sponsors (3)

Lead Sponsor	Collaborator
University of Turin, Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino, Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic control 2	The blood carbonate of the patients are measured at the onset to define ketoacidosis	at onset
Primary	Metabolic control	The blood pH of the patients are measured at the onset to define ketoacidosis following normal standard hospital procedure.	at onset
Secondary	Body mass index	calculated as (weight (kg))/(height (meters))exp2	at onset
Secondary	Glycated hemoglobin	in % and as mmol/mol	at onset
Secondary	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)	at onset
Secondary	vitamin D	evaluated from serum sample as 25-hydroxyvitamin D (ng/ml)	at the onset
Secondary	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)	at onset
Secondary	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)	at onset
Secondary	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)	at onset