T1DM Clinical Onset and Progression in Paediatric Population

NCT03547440 | Completed

• 2 other identifiers: G12114000080001RF-2011-02350617
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus; immigrant; microbiota; bioindicator; Methanobrevibacter smithii

Outcome Measures

Primary Outcomes (1)

• Metabolic control

  The blood pH of the patients are measured at the onset to define ketoacidosis following normal standard hospital procedure.

  at onset

Secondary Outcomes (7)

• Body mass index

  at onset

• Glycated hemoglobin

  at onset

• Diet behaviour

  at onset

• vitamin D

  at the onset

• Microbiome bioindicators

  at onset

Other Outcomes (1)

• Metabolic control 2

  at onset

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (3)

Pediatric Clinic - Hospital "Maggiore della Carità" of Novara

Novara, Italy

Location

Dept. of Public Health and Pediatrics

Torino, 10126, Italy

Location

Dep. of Medicine Science

Turin, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

stool samples (from all the participants) and blood samples (only from T1DM) patients

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Roberta T Siliquini, Prof.

  University of Turin - Hygiene and Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: June 6, 2018
• Study Start: March 18, 2015
• Primary Completion: June 30, 2017
• Study Completion: September 18, 2018
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)