T1DM Clinical Onset and Progression in Paediatric Population (Bioda)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease|
|Type 1 Diabetes Mellitus|
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.
- 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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||94 participants|
|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|
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.
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
- 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.
- Body mass index [ Time Frame: at onset ]calculated as (weight (kg))/(height (meters))exp2
- Glycated hemoglobin [ Time Frame: at onset ]in % and as mmol/mol
- 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)
- vitamin D [ Time Frame: at the onset ]evaluated from serum sample as 25-hydroxyvitamin D (ng/ml)
- 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)
- 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)
- 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)
- 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
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
|Pediatric Clinic - Hospital "Maggiore della Carità" of Novara|
|Dept. of Public Health and Pediatrics|
|Torino, Italy, 10126|
|Dep. of Medicine Science|
|Principal Investigator:||Roberta T Siliquini, Prof.||University of Turin - Hygiene and Preventive Medicine|