Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT06070103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Depression ,Anxiety and Stress Disorders Among Diabetic Patients in Assuit University Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 325}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-09-30', 'studyFirstSubmitQcDate': '2023-09-30', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression ,Anxiety and stress disorders among diabetic patients in Assuit University Hospitals.', 'timeFrame': 'Baseline', 'description': '1. Assessment the prevalence of psychiatric disorders in diabetic patient in Assuit University Hospital.\n2. Determine the associated factors with the psychiatric disorders.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'anxiety', 'stress'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '1. Assessment the prevalence of psychiatric disorders in diabetic patient in Assuit University Hospital.\n2. Determine the associated factors with the psychiatric disorders.', 'detailedDescription': "Across the world, both Diabetes and Psychiatric disorders are on rise. Diabetes strongly affects disability, mortality, and global health expenditure. Diabetes mellitus is a disabling long-term health condition that is common and growing. Globally, it affects 10.5% of the population and is the leading cause of lost disability-adjusted life years Type 1 diabetes is a lifelong autoimmune disease characterized by insulin deficiency and resultant hyperglycemia. It constitutes around 10% of all diagnosed cases of diabetes and its incidence is increasing globally. Type 2 diabetes mellitus (DM2) is a chronic metabolic disease characterized by an increase in normal serum glucose levels (hyperglycemia).\n\nPsychological disorders can occur in people with diabetes of all ages. Type 1 diabetes seems to have a higher prevalence of psychological disorders than type 2 diabetes.\n\nAbout 15%-20% of people with diabetes are suffering from depression. the exact cause of depression in people with diabetes is unknown, it is likely complex due to a combination of genetic, physiological, and psychological factors. Depression and anxiety could worsen the prognosis of diabetes by reducing the patients' ability to self-care and increasing non-compliance to treatments while increasing the risk of serious short-term and long-term complications such as blindness, amputations, stroke, and even premature death."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 diabetes is a lifelong autoimmune disease characterized by insulin deficiency and resultant hyperglycemia. It constitutes around 10% of all diagnosed cases of diabetes and its incidence is increasing globally. Type 2 diabetes mellitus (DM2) is a chronic metabolic disease characterized by an increase in normal serum glucose levels (hyperglycemia).', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge between 18 and 70 years Diagnosed according to criteria of the American Diabetes Association fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher or A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT).\n\nExclusion Criteria:\n\n* Patient with cognitive difficulties\n* To be very sick and unable to give consent\n* Women who were pregnant or had given birth in the last 6 months'}, 'identificationModule': {'nctId': 'NCT06070103', 'briefTitle': 'Depression ,Anxiety and Stress Disorders Among Diabetic Patients in Assuit University Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Depression, Anxiety and Stress Disorders Among Diabetic Patients in Assuit University Hospitals', 'orgStudyIdInfo': {'id': 'D,A,S among diabetic Patients'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alaa ab mohamed, master', 'role': 'CONTACT', 'email': 'dr.alaa2199@gmail.com', 'phone': '01142876510'}, {'name': 'Dalia G Mahran, Professor', 'role': 'CONTACT', 'email': 'Daliaym2001@yahoo.com', 'phone': '01007120821'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Alaa Abdelmoaty Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}