DiabetesDiapepsyNCT03323281
Neuropsychiatric Factors
An observational study of Diabetes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their period. The appearance of a trophic disorder in a diabetic patient is a serious complication, indicating that diabetes is often complicated. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Neuropsychological assessments
- How many people
- 266 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2019to 7 Jun 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 133 diabetic subjects with foot wounds and 133 diabetic subjects without foot wounds
Who may be able to join
- "Diabetic subjects with foot wounds"
- Subjects over 45 years old
- Diabetic type 1 or type 2 with foot wound (podological risk grade 3) in hospitalization in the Nutrition-Diabetes Unit CHU Lapeyronie or in the Department of Metabolic Diseases CHRU Grau du Roi.
- Having given their informed consent for the study
- "Diabetic subjects without a foot wound"
- Subjects over 45 years old
- Type 1 or type 2 diabetics without a foot wound or previous foot wound (grade 0 to 2 grade, including Charcot foot) hospitalized or seen for consultation in the Nutrition-Diabetes Unit LaUyronie CHU or Metabolic Diseases CHRU Grau of the King.
- Having given their informed consent for the study
Who cannot join
- Patients who can not complete the self-questionnaires or can not carry out the cognitive tests (blindness, non-French speaking patient, illiteracy)
- Major physical or neurosensory problems that may interfere with the tests
Trial locations and contacts
1 site in 1 country.
Sylvain ARTERO, PhD contact
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Ariane SULTAN, PR
About this study
Official title: Impact of Cognitive, Psychological and Psychiatric Factors in Pathogenesis of Diabetic Foot and Recurrence : Study in Diabetic Patients
It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their period. The appearance of a trophic disorder in a diabetic patient is a serious complication, indicating that diabetes is often complicated. The consequences are serious for the patient with an impairment of his quality of life, but also for society with a high cost in terms of health care costs.
It should also be noted that diabetes remains the main cause of non-traumatic amputation in most developed countries, with amputation often preceded by a trophic disorder. In addition, 20% of amputees are re-amputated at least once a year. Thus, the consequences of diabetic foot injuries are important in human, social and health terms and are the subject of increased health care spending.
Read more
Many studies have shown that diabetes is a risk factor for dementia, whether it is Alzheimer's disease, Alzheimer's disease or the vascular component or pure vascular dementia.
However, an understanding of the cognitive mechanisms involved in the management of diabetes and in particular in the diabetic foot and its recurrence remains partial and no study has integrated the severity of the risk of the foot (evaluated by the podological risk) Specific implication of some Cognitive abilities, especially in relation to episodic memory, and social cognition integrating decision-making abilities. These specific disorders could have a major impact in diabetes follow-up, therapeutic adherence and the risk of developing recurrent trophic disorders.
Thus, the coexistence of diabetes with a mental pathology makes the management of the subject more complex and exposes it to more complications.
In the management of chronic diabetic disease, adherence to treatment is essential. It is therefore important to detect the specific effects of this type of personality on the prognosis of diabetes and the appearance of foot wounds.
Read the detailed description
It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their. The occurrence of a trophic disorder in a diabetic patient is a serious complication, indicating a diabetes often complicated. The consequences are severe for the patient with an alteration of his quality of life, but also for society with a high cost in terms of healthcare costs.
It should also be pointed out that diabetes is still the leading cause of non-traumatic amputation in most developped countries, with amputation often preceded by a trophic disorder. Further, 20% of amputees are re-amputed at least once a year. Thus the consequences of the wounds of the diabetic foot are important on the human, social and health level and are the subject of an increase of the health expenses.
Many studies have shown that diabetes is a risk factor for dementia whether it is Alzheimer's disease, Alzheimer's disease with vascular component or pure vascular dementia.
However, an understanding of the cognitive mechanisms involved in the management of diabetes and in particular in the diabetic foot and its recurrence remains partial and no study has integrated the severity of the foot risk (evaluated by the podological risk ) and the specific involvement of certain cognitive abilities, in particular in relation to episodic memory, and social cognition integrating decision-making abilities. These specific disorders could have a major implication in the follow-up of diabetes, in the therapeutic adherence and in the risk of developing recurrent trophic disorders.
Thus, the coexistence of diabetes with a mental pathology makes the management of the subject more complex and exposes it to more complications.
In the management of chronic diabetic disease, adherence to treatment is essential. It is therefore important to detect the specific effects of this type of personality on the prognosis of diabetes and the occurrence of foot wounds.
- Conditions
- Diabetes
- Being tested
- Neuropsychological assessments
- Keywords
- Diabetic foot, Cognitive functions, Psychiatric disorders, Neurology, Psychiatry
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentsOther
Maintenance of approximately 1h30 with a neuropsychologist or a physician trained in neuropsychological assessments in Diabetic Type 1 or Type 2 with foot wound hospitalization and Diabetic Type 1 or Type 2 without a foot wound or antecedent Of foot wound (podological risk grade 0 to 2, including foot of Charcot)
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Type 1 or Type 2 with foot wound | Type 1 or type 2 diabetic patients with hospitalization for foot wounds having an interview with a neuropsychologist or a physician trained in neuropsychological assessments Receives: Other: Neuropsychological assessments | |
| Diabetic Type 1 or Type 2 without a foot wound or antecedent | Type 1 or Type 2 diabetic patients with no foot wounds or history of foot wounds having an interview with a neuropsychologist or a physician trained in neuropsychological assessments Receives: Other: Neuropsychological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring memory
The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure
- Range : min :0 max:16
- better or worse outcome according the population studied (age, education) (no cut off scores)
Measured: 1 day
Secondary outcomes (1)
Measuring memory
The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure
- Range : min :0 max:16
- better or worse outcome according the population studied (age, education) (no cut off scores)
Measured: 2 years after the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start7 Dec 2019
- Primary completion7 Dec 2024 (estimated)
- Study completion7 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane SULTAN, PR, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323281
- Sponsor's protocol ID
- UF9805
- Acronym
- Diapepsy
- Status last verified
- Dec 2021
- First submitted
- 16 May 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cognitive, Psychological and Psychiatric Factors in Pathogenesis of Diabetic Foot and Recurrence : Study in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03323281
- Acronym / sponsor ID
- Diapepsy / UF9805
- Conditions
- Diabetes
- Keywords
- Diabetic foot, Cognitive functions, Psychiatric disorders, Neurology, Psychiatry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 7 Dec 2024 (estimated)
- Study completion
- 7 Jun 2025 (estimated)
- First posted
- 26 Oct 2017 (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.
It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their period. The appearance of a trophic disorder in a diabetic patient is a serious complication, indicating that diabetes is often complicated. The consequences are serious for the patient with an impairment of his quality of life, but also for society with a high cost in terms of health care costs.
It should also be noted that diabetes remains the main cause of non-traumatic amputation in most developed countries, with amputation often preceded by a trophic disorder. In addition, 20% of amputees are re-amputated at least once a year. Thus, the consequences of diabetic foot injuries are important in human, social and health terms and are the subject of increased health care spending.
Many studies have shown that diabetes is a risk factor for dementia, whether it is Alzheimer's disease, Alzheimer's disease or the vascular component or pure vascular dementia.
However, an understanding of the cognitive mechanisms involved in the management of diabetes and in particular in the diabetic foot and its recurrence remains partial and no study has integrated the severity of the risk of the foot (evaluated by the podological risk) Specific implication of some Cognitive abilities, especially in relation to episodic memory, and social cognition integrating decision-making abilities. These specific disorders could have a major impact in diabetes follow-up, therapeutic adherence and the risk of developing recurrent trophic disorders.
Thus, the coexistence of diabetes with a mental pathology makes the management of the subject more complex and exposes it to more complications.
In the management of chronic diabetic disease, adherence to treatment is essential. It is therefore important to detect the specific effects of this type of personality on the prognosis of diabetes and the appearance of foot wounds.
Detailed description
It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their. The occurrence of a trophic disorder in a diabetic patient is a serious complication, indicating a diabetes often complicated. The consequences are severe for the patient with an alteration of his quality of life, but also for society with a high cost in terms of healthcare costs.
It should also be pointed out that diabetes is still the leading cause of non-traumatic amputation in most developped countries, with amputation often preceded by a trophic disorder. Further, 20% of amputees are re-amputed at least once a year. Thus the consequences of the wounds of the diabetic foot are important on the human, social and health level and are the subject of an increase of the health expenses.
Many studies have shown that diabetes is a risk factor for dementia whether it is Alzheimer's disease, Alzheimer's disease with vascular component or pure vascular dementia.
However, an understanding of the cognitive mechanisms involved in the management of diabetes and in particular in the diabetic foot and its recurrence remains partial and no study has integrated the severity of the foot risk (evaluated by the podological risk ) and the specific involvement of certain cognitive abilities, in particular in relation to episodic memory, and social cognition integrating decision-making abilities. These specific disorders could have a major implication in the follow-up of diabetes, in the therapeutic adherence and in the risk of developing recurrent trophic disorders.
Thus, the coexistence of diabetes with a mental pathology makes the management of the subject more complex and exposes it to more complications.
In the management of chronic diabetic disease, adherence to treatment is essential. It is therefore important to detect the specific effects of this type of personality on the prognosis of diabetes and the occurrence of foot wounds.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Type 1 or Type 2 with foot wound | – | Other: Neuropsychological assessmentsType 1 or type 2 diabetic patients with hospitalization for foot wounds having an interview with a neuropsychologist or a physician trained in neuropsychological assessments |
| Diabetic Type 1 or Type 2 without a foot wound or antecedent | – | Other: Neuropsychological assessmentsType 1 or Type 2 diabetic patients with no foot wounds or history of foot wounds having an interview with a neuropsychologist or a physician trained in neuropsychological assessments |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 133 diabetic subjects with foot wounds and 133 diabetic subjects without foot wounds
Key inclusion criteria (8 listed)
- "Diabetic subjects with foot wounds"
- Subjects over 45 years old
- Diabetic type 1 or type 2 with foot wound (podological risk grade 3) in hospitalization in the Nutrition-Diabetes Unit CHU Lapeyronie or in the Department of Metabolic Diseases CHRU Grau du Roi.
- Having given their informed consent for the study
- "Diabetic subjects without a foot wound"
Key exclusion criteria (2 listed)
- Patients who can not complete the self-questionnaires or can not carry out the cognitive tests (blindness, non-French speaking patient, illiteracy)
- Major physical or neurosensory problems that may interfere with the tests
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 |
|---|---|---|
| Neuropsychological assessmentsMaintenance of approximately 1h30 with a neuropsychologist or a physician trained in neuropsychological assessments in Diabetic Type 1 or Type 2 with foot wound hospitalization and Diabetic Type 1 or Type 2 without a foot wound or antecedent Of foot wound (podological risk grade 0 to 2, including foot of Charcot) | Other | Diabetic Type 1 or Type 2 with foot wound, Diabetic Type 1 or Type 2 without a foot wound or antecedent |
Primary outcome
Measuring memory
Time frame: 1 day
The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure * Range : min :0 max:16 * better or worse outcome according the population studied (age, education) (no cut off scores)
1 secondary outcome
Measuring memory
Time frame: 2 years after the hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Sylvain ARTERO, PhD contact
Ariane SULTAN, PR study director
University Hospital, Montpellier
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 Diabetes, run by University Hospital, Montpellier 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane SULTAN, PR (467338402 ext. 33, a-sultan@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring memory (time frame: 1 day). 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 21 Dec 2021.