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T1DM Clinical Onset and Progression in Paediatric Population (Bioda)

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ClinicalTrials.gov Identifier: NCT03547440
Recruitment Status : Unknown
Verified June 2018 by Deborah Traversi, University of Turin, Italy.
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Azienda Ospedaliero Universitaria Maggiore della Carita
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Information provided by (Responsible Party):
Deborah Traversi, University of Turin, Italy

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.

Condition or disease
Type 1 Diabetes Mellitus

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]

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Study Type : Observational [Patient Registry]
Actual Enrollment : 94 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Determinants of Type 1 Diabetes (T1DM) Clinical Onset and Progression in Paediatric Immigrant Population
Actual Study Start Date : March 18, 2015
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : September 18, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Body mass index [ Time Frame: at onset ]
    calculated as (weight (kg))/(height (meters))exp2

  2. Glycated hemoglobin [ Time Frame: at onset ]
    in % and as mmol/mol

  3. Diet behaviour [ Time Frame: at onset ]
    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)

  4. vitamin D [ Time Frame: at the onset ]
    evaluated from serum sample as 25-hydroxyvitamin D (ng/ml)

  5. Microbiome bioindicators [ Time Frame: at onset ]
    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)

  6. Methanobrevibacter smithii [ Time Frame: at onset ]
    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)

  7. Akkermansia muciniphila quantification in stool [ Time Frame: at onset ]
    Starting from the stool DNA extracted, following bioindicator measured by quantitative Real Time Polymerase Chain Reaction : Akkermansia muciniphila (num copies 16SrDNA /g stool)


Other Outcome Measures:
  1. Metabolic control 2 [ Time Frame: at onset ]
    The blood carbonate of the patients are measured at the onset to define ketoacidosis


Biospecimen Retention:   Samples With DNA
stool samples (from all the participants) and blood samples (only from T1DM) patients


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547440


Locations
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Italy
Pediatric Clinic - Hospital "Maggiore della Carità" of Novara
Novara, Italy
Dept. of Public Health and Pediatrics
Torino, Italy, 10126
Dep. of Medicine Science
Turin, Italy
Sponsors and Collaborators
University of Turin, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Investigators
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Principal Investigator: Roberta T Siliquini, Prof. University of Turin - Hygiene and Preventive Medicine
Additional Information:

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Responsible Party: Deborah Traversi, Associate Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT03547440    
Other Study ID Numbers: G12114000080001
RF-2011-02350617 ( Other Grant/Funding Number: Italian Health Minister )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Deborah Traversi, University of Turin, Italy:
Type 1 Diabetes Mellitus
immigrant
microbiota
bioindicator
Methanobrevibacter smithii
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases