Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04705558
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Ketogenic Diet and Exercise on Prediabetes in Female With Normal Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two intervention:combination of continuous aerobic exercise in form of treadmill 5 sessions per week and ketogenic diet.\n\nketogenic diet alone.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-09', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in fasting plasma glucose', 'timeFrame': 'three month', 'description': "Fasting blood specimen was obtained and measured participants' fasting plasma glucose.\n\nDiagnosed Prediabetes was stated as any participants who did not have diabetes but who had fasting plasma glucose level of 5.6 - 7.0 mmol/L"}, {'measure': 'change in glycated hemoglobin', 'timeFrame': 'three month', 'description': "Fasting blood specimen was obtained and measured participants' glycated hemoglobin (HbA1c) Diagnosed Prediabetes was stated as any participants who did not have diabetes but who had HbA1c level of 5.7% - 6.4%"}], 'secondaryOutcomes': [{'measure': 'change in Body composition', 'timeFrame': 'three month', 'description': 'Body Weight was measured in kilograms and Height was measured in meters then body mass index (BMI) was calculated by dividing weight in kilograms on height in meters square BMI = kg/m2 .\n\nWaist circumference measurements have been made to the nearest 0.1 centimeter using a tape measure at the uppermost lateral border of the hip crest (ilium)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PreDiabetes']}, 'descriptionModule': {'briefSummary': 'Individuals with prediabetes have a high risk of developing type 2 diabetes. The purpose of this study was to compare the effect of combination of ketogenic diet and aerobic exercise interventions versus ketogenic diet alone on the glucose level in prediabetes female with normal weight.', 'detailedDescription': 'Pre-diabetes is the preceding condition of diabetes, where the blood sugar level is higher than normal but lower than the diagnostic criteria of type II diabetes and in most of the cases, this ultimately leads to the development type II diabetes. It has been estimated that the number of pre-diabetic cases will increase to more than 470 million people worldwide, and this is understandably a worrying trend . Many studies have been done on diabetes patients. However, little is known about the pre-diabetic conditions.\n\nDiagnosed Prediabetes was stated as any participants who did not have diabetes but who had fasting plasma glucose level of 100 - 125 mg/dL, an HbA1c level of 5.7% - 6.4%, or 2-hour plasma glucose level of 140 - 199 mg/dL.\n\nTreatment of pre-diabetes and prevention of the development of pre-diabetes to T2DM,through lifestyle intervention mainly includes nutritious dietary and exercises.\n\nCombining a ketogenic diet with exercise is a powerful way to reducing insulin resistance, control blood glucose levels and achieve weight loss. As ketogenic diets are nowadays predictable as being useful, there is presently a shortage of research studies examining just how useful the combination of exercise and a ketogenic diet'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'female with prediabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. female with their age ranged from 40-60 years\n2. body mass index (BMI) from 20-25 kg/m2\n3. fasting serum glucose range 5.6 to 6.9 mmol/L\n4. hemoglobin A1C value fell within the prediabetes range (5.7%-6.4%) without medications, or treatment with oral hypoglycemic agents and/or insulin.\n\nExclusion criteria:\n\n1. renal insufficiency\n2. liver disease\n3. abnormal cardiovascular function\n4. diabetes\n5. untreated hypertension\n6. dyslipidemia\n7. abnormal thyroid function\n8. anyone who has undergone gallbladder removal\n9. musculoskeletal constraint preventing them from fully participating in the exercise intervention'}, 'identificationModule': {'nctId': 'NCT04705558', 'briefTitle': 'Combination of Ketogenic Diet and Exercise on Prediabetes in Female With Normal Weight', 'organization': {'class': 'OTHER', 'fullName': 'Badr University'}, 'officialTitle': 'Combination of Ketogenic Diet and Aerobic Exercise Versus Ketogenic Diet Alone in Prediabetes Female With Normal Weight', 'orgStudyIdInfo': {'id': 'KETO , EXERCISE ON PREDIABETES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group I', 'description': 'Continuous aerobic exercise with ketogenic diet for three month', 'interventionNames': ['Other: continuous moderate intensity aerobic training', 'Other: ketogenic diet']}, {'type': 'EXPERIMENTAL', 'label': 'group II', 'description': 'Ketogenic diet alone for three month', 'interventionNames': ['Other: ketogenic diet']}], 'interventions': [{'name': 'continuous moderate intensity aerobic training', 'type': 'OTHER', 'description': 'continuous moderate intensity aerobic exercises with ketogenic diet group underwent supervised moderate-intensity exercised on a treadmill at 50%-70% of heart rate reserve for three month', 'armGroupLabels': ['group I']}, {'name': 'ketogenic diet', 'type': 'OTHER', 'description': 'Ketogenic diet: a low carbohydrate high-fat diet consisted of the following nutrient conformation: 80% fat, 15% protein and 5% carbohydrates, entire daily intake was estimated to be 20-30 g of carbohydrates for three month.', 'armGroupLabels': ['group I', 'group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mona Mohamed Abdelkhalek, LECTURER', 'role': 'CONTACT', 'email': '3m.sons@gmail.com', 'phone': '002021024056108'}], 'facility': 'Mona Mohamed Abdelkhalek', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mona Abdelkhalek, lecturer', 'role': 'CONTACT', 'email': '3m.sons@gmail.com', 'phone': '002021024056108'}, {'name': 'Mona Abdelkhalek, lecturer', 'role': 'CONTACT', 'email': 'Mona.Abdelkhalek@buc.edu.eg', 'phone': '002021024056108'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Mona Mohamed Abdelkhalek', 'investigatorAffiliation': 'Badr University'}}}}