Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-13 @ 1:48 AM
Study NCT ID:
NCT06528002
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2024-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of hyprid method of insulin in type 2 diabetic patients during fasting in ramadan', 'timeFrame': '4 weeks after ramadan', 'description': 'This is a study aiming to assess the safety and efficacy of our hybrid method compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting. and this done by measurement of blood glucose level 7 times daily to detect control of blood glucose during fasting in ramadan .then will measure fasting and postprandial blood glucose level after ramadan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 DM.fasting in ramadan .insulin therapy'], 'conditions': ['Continous Blood Glucose Monitoring', 'Calculation of Body Mass Index', 'Measurment of Blood Pressure']}, 'descriptionModule': {'briefSummary': "All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). frequently fast throughout Ramadan. However, many Muslim patients insist on fasting in spite of medical warning. So, the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting.", 'detailedDescription': "All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). frequently fast throughout Ramadan.\n\nAlthough fasting during Ramadan is said to have positive effects on diabetes patients, such as a reduction in excess body weight and an improvement in lipid profile, it can be linked to a slight increased risk for metabolic complications that need immediate attention, such as hypoglycemia and hyperglycemia, dehydration, and diabetic ketoacidosis (DKA)\n\nSimilarly, an increase in hyperglycemic episodes was also noted in another study conducted by the Benghazi Diabetes and Endocrine Centre (BDEC) on 493 T2DM patients fasting during Ramadan where 10.7% experienced hyperglycemia. Therefore, appropriate treatment adjustments including insulin regimen are necessary to avoid both hypo and hyperglycemia during Ramadan fasting.\n\nT2DM patients well-controlled on premixed insulin or multiple doses injections should not fast, and they have the legitimate exemption for this. However, many Muslim patients insist on fasting inspite of medical warning. So, the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will carry out on Muslim type 2 DM patients willing to fast Ramadan during the year 2024 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egyptian male and female Muslim patients,With T2DM, willing to fast Ramadan\n\n * . age ≥ 18 years old.\n * . type 2 diabetic patients treated with premixed insulin alone or combined with oral antidiabetic drugs (metformin, sulfonylurea: gliclazide, dipeptidyl peptidase 4 Inhibitor: sitagliptin or vildagliptin or thiazolidinediones/glitazones).\n\nExclusion Criteria:\n\n* type 1 diabetic patients\n* uncontrolled type 2 diabetics (HbA1c \\> 9; but they were included if insisting on fasting despite the detailed medical advice very high-risk diabetics (according to IDF 2021 classification)9\n* newly diagnosed as diabetics (\\< 3 months)\n* patients with previous ketoacidosis or hyperosmolar hyperglycemic states, recurrent or severe hypoglycemia within the past 2 months\n* type 2 diabetic patients with hypoglycemic unawareness.\n* Hospitalized patients, besides pregnant and lactating females'}, 'identificationModule': {'nctId': 'NCT06528002', 'briefTitle': 'Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan: Safety and Efficacy', 'orgStudyIdInfo': {'id': 'Soh-Med-24-05--02PD.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'type 2 diabetic patients take normal breakfast dose at Iftar and take 50% of dinner dose as short acting insulin at Suhoor with giving metformin dose after Suhoor even if giving once per day.'}, {'label': 'Group 2', 'description': 'patients on regmin as recommendations of IDF take normal breakfast dose at Iftar and Reduce Suhoor dose by 20-50% of dinner premixed dose.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag Faculty of Medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Sara Kasem Abdelal, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag university .faculty of medicine'}, {'name': 'Ahmed Faysal El_Rawy, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag university .faculty of medicine'}, {'name': 'Marwa zanaty Elsayed, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag university .faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of internal medicine', 'investigatorFullName': 'Hany Ahmed Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}