Type 2 DiabetesCHARCOTEXNCT06096935
Exome Evaluation in Patients Living With Diabetes Complicated by Charcot Neuroarthropathy.
An observational study of Type 2 Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- bood sample
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2024to 18 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patiens living with type 2 diabetes complicates by Charcot Neuroarthopathy
Who may be able to join
- 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.
Who cannot join
- Subject under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
In patients living with diabetes, a rare and devastating joint complication known as Charcot's neuroarthropathy (CN) has been observed. The clinical presentation of this complication is characterized by activation of inflammation and bone remodeling markers, disruption of the osteoblast and osteoclast system, activation of the RANKL (Receptor activator of nuclear factor-kappa B ligand) system and its antagonist osteoprotegerin (OPG), and often a fatigue fracture due to physical activity.
The pathogenic mechanisms of CN have been the subject of much debate, and there are a number of competing theories which are not necessarily exclusive.
CN patients have been shown to have reduced bone density in the lower limbs compared with neuropathic subjects. Studies using bone markers to assess bone formation and resorption demonstrated that there is an increase in osteoclastic activity relative to osteoblastic activity in both acute and chronic forms of CN. In 2007, W.J. Jeffcoate described CN as an increased inflammatory response to injury inducing increased bone lysis. Since the emergence of this theory, a significant number of studies have evaluated inflammatory factors and bone modeling in patients with CN, such as C-reactive protein, TNF α and IL6. Three studies showed an increase in their levels in the setting of CN.
otherwise known genes, or new genes implicated 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
- Being tested
- bood sample
- Keywords
- type 2 Diabetes, CHARCOT neuroarthropathy, Exome
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bood sampleOther
Exome measurements
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients with type 2 diabetes complicated by active or chronic Charcot neuropathy Receives: Other: bood sample | |
| Group 2 | patients living with type 2 diabetes without active or chronic Charcot neuroarthropathy. Receives: Other: bood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 0
Secondary outcomes (1)
exome variations
Identification of "Group1" specific candidate variant(s)/gene(s)
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start11 Jul 2024
- Primary completion18 Jan 2025
- Study completion18 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096935
- Sponsor's protocol ID
- 2023-A01254-41
- Acronym
- CHARCOTEX
- Status last verified
- May 2026
- First submitted
- 16 Oct 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exome Evaluation in Patients Living With Diabetes Complicated by Charcot Neuroarthropathy.
- ClinicalTrials.gov ID
- NCT06096935
- Acronym / sponsor ID
- CHARCOTEX / 2023-A01254-41
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 Diabetes, CHARCOT neuroarthropathy, Exome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 18 Jan 2025 (actual)
- Study completion
- 18 Jan 2025 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
In patients living with diabetes, a rare and devastating joint complication known as Charcot's neuroarthropathy (CN) has been observed. The clinical presentation of this complication is characterized by activation of inflammation and bone remodeling markers, disruption of the osteoblast and osteoclast system, activation of the RANKL (Receptor activator of nuclear factor-kappa B ligand) system and its antagonist osteoprotegerin (OPG), and often a fatigue fracture due to physical activity.
The pathogenic mechanisms of CN have been the subject of much debate, and there are a number of competing theories which are not necessarily exclusive.
CN patients have been shown to have reduced bone density in the lower limbs compared with neuropathic subjects. Studies using bone markers to assess bone formation and resorption demonstrated that there is an increase in osteoclastic activity relative to osteoblastic activity in both acute and chronic forms of CN. In 2007, W.J. Jeffcoate described CN as an increased inflammatory response to injury inducing increased bone lysis. Since the emergence of this theory, a significant number of studies have evaluated inflammatory factors and bone modeling in patients with CN, such as C-reactive protein, TNF α and IL6. Three studies showed an increase in their levels in the setting of CN.
otherwise known genes, or new genes implicated 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: bood samplepatients with type 2 diabetes complicated by active or chronic Charcot neuropathy |
| Group 2 | – | Other: bood samplepatients living with type 2 diabetes without active or chronic Charcot neuroarthropathy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patiens living with type 2 diabetes complicates by Charcot Neuroarthopathy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject under guardianship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bood sampleExome measurements | Other | Group 1, Group 2 |
Primary outcome
exom
Time frame: at day 0
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
1 secondary outcome
exome variations
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exom (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.