Neuropsychiatric Factors

Diabetes Clinical Trial

— Diapepsy  

Official title:

Impact of Cognitive, Psychological and Psychiatric Factors in Pathogenesis of Diabetic Foot and Recurrence : Study in Diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323281
• Other study ID #: UF9805
• Status: Recruiting
• Start date: December 7, 2019
• Est. completion date: June 7, 2025

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: Ariane SULTAN, PR
• Phone: 467338402
• Email: a-sultan[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: June 7, 2025
• Est. primary completion date: December 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

"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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot

Intervention

Other:
• Neuropsychological assessments
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)

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Inserm U1061 : Neuropsychiatry

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of cognition by the Mini Mental State Examination (MMSE)	Measures of cognition by the realization of Mini Mental State Examination (MMSE); Range min :0 max 30; Score < or = 24 : cognitive disorders This test will be performed over 1 day during hospitalization	1 day
Other	Weschler Cognition Measures	Weschler Cognition Measurements This test will be performed over 1 day during hospitalization	1 day
Other	Measurement of cognition by the EMPAN direct and indirect	Measurement of cognition by the EMPAN direct and indirect EMPAN direct : Range : 1-8 and no cut off score EMPAN indirect : Range : 1-8 and no cut off score; This test will be performed over 1 day during hospitalization	1 day
Other	Measurement of cognition by the Trail Making A (TMTA) and Trail Making B (TMTB)	Measurement of cognition by the TMTA and TMTB Trail Making A : Range : 0-26 and no cut off score Trail Making B : Range : 0-13 and no cut off score This test will be performed over 1 day during hospitalization	1 day
Other	Measurement of cognition by the phonemic verbal fluence	Measurement of cognition by the phonemic verbal fluence This test will be performed over 1 day during hospitalization	1 day
Other	Measurement of cognition by the semantic verbal fluence	Measurement of cognition by the semantic verbal fluence This test will be performed over 1 day during hospitalization	1 day
Other	Measurement of cognition by the phonemic verbal fluence	Measurement of cognition by the phonemic verbal fluence	2 years after the hospitalization
Other	Measurement of cognition by the semantic verbal fluence	Measurement of cognition by the semantic verbal fluence	2 years after the hospitalization
Other	Measurement of cognition by the the Trail Making A (TMTA) and Trail Making B (TMTB)	Measurement of cognition by the TMTA and TMTB; Trail Making A : Range : 0-26 and no cut off score Trail Making B : Range : 0-13 and no cut off score	2 years after the hospitalization
Other	Measurement of cognition by the empan direct and indirect	Measurement of cognition by the EMPAN direct and indirect EMPAN direct : Range : 1-8 and no cut off score EMPAN indirect : Range : 1-8 and no cut off score	2 years after the hospitalization
Other	Weschler Cognition Measures	Weschler Cognition Measurements	2 years after the hospitalization
Other	Measurement of cognition by the Mini Mental State Examination (MMSE)	Measures of cognition by the realization of Mini Mental State Examination (MMSE); Range min :0 max 30; Score < or = 24 : cognitive disorders	2 years after the hospitalization
Primary	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)	1 day
Secondary	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)	2 years after the hospitalization