Exome Evaluation in Patients Living with Diabetes Complicated by Charcot Neuroarthropathy.

NCT06096935 | Completed

• 1 other identifier: 2023/0025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes, like obesity, has reached worldwide proportions such that we're talking about a pandemic. These two diseases are a major cause of mortality and multiple complications. The medical and financial stakes involved make these two diseases a major public health issue. Two groups of factors contribute to these diseases: the environment and genetics. The use of next-generation sequencing (NGS) is a highly relevant tool for identifying mutations in already known genes, or new genes involved in the disease, for diagnostic purposes. This approach makes it possible to validate previously described genes and/or discover new loci linked to new signalling pathways involved in the pathophysiology of Charcot's foot in patients with diabetes

Conditions

Type 2 Diabetes

Keywords

type 2 Diabetes; CHARCOT neuroarthropathy; Exome

Outcome Measures

Primary Outcomes (1)

• exom

  Exome measurement at the time of inclusion (D0) via a differential statistical analysis of the "burden" type aimed at comparing the organization of the mutational load between the two study groups

  at day 0

Secondary Outcomes (1)

• exome variations

  at day 0

Study Arms (2)

Group 1

patients with type 2 diabetes complicated by active or chronic Charcot neuropathy

Other: bood sample

Group 2

patients living with type 2 diabetes without active or chronic Charcot neuroarthropathy.

Other: bood sample

Interventions

bood sample OTHER

Exome measurements

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patiens living with type 2 diabetes complicates by Charcot Neuroarthopathy

You may qualify if:

• Men or women aged 18 to 70
• with type 2 diabetes for at least one year
• with active or chronic Charcot neuroarthropathy (Group 1) OR
• never had Charcot neuroarthropathy (Group 2)
• Have agreed to participate in the study and have signed an informed consent form.

You may not qualify if:

• \- Subject under guardianship or curatorship.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 24, 2023
• Study Start: July 11, 2024
• Primary Completion: January 18, 2025
• Study Completion: January 18, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)