Research Study for Rare Pathogenic Mutations Causing Type 2 Diabetes and Complications

NCT04700813 | Unknown DMC

• 2 other identifiers: 2019-166B707201940651
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center trial The goal is to better understand the various genetic mutations encountered in cases of type 2 diabetes as well as their frequency of occurrence in the population. Such analyzes also make it possible to develop personalized medicine and to be able to prevent the associated risks. The aim of this work is also to demonstrate the value of a systematic genetic diagnosis of patients with DMT2 in order to improve their clinical management. Taking a blood sample, which will consist of the single sample from the entire study (1 single visit, combined with a follow-up visit to the patient's usual diabetist). Participation in this study would make it possible to diagnose rare pathogenic mutations in type 2 diabetes and therefore to be able to adapt the treatment in a specific and personal way depending on the presence or not of the mutations and also to prevent the appearance of other pathologies.

Conditions

Diabete Type 2

Outcome Measures

Primary Outcomes (1)

• pathogenic mutations causing type 2 diabetes

  24 months

Interventions

search for rare pathogenic mutations DIAGNOSTIC_TEST

search for rare pathogenic mutations causing diabetes type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

type 2 diabetic patients monitored for this pathology at the study site academic hospital of Liège

You may qualify if:

• diabetes type 2

You may not qualify if:

• Refusal of participation
• Type 1 diabetic
• Presence of auto-antibodies directed against the β cells of the pancreas (insulin-secreting)

Sponsors & Collaborators

• University of Liege: lead
• EGID, Lille: collaborator

Study Sites (1)

Marjorie Fadeur

Liège, 4000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* 1 × 5mL of blood on EDTA for DNA extraction, * 4 × 5 mL of blood in a dry tube for the constitution of a serum bank, * 2 × 5 mL of blood on EDTA for the preservation of the plasma for the subsequent performance of additional analyzes as part of a positive genetic diagnosis. Au total : 35 mL de sang seront prélevés.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nicolas Paquot

CONTACT

+323662942; nicolas.paquot@chuliege.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 8, 2021
• Study Start: September 13, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

BE (1)