Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT05713058
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Early Time-restricted Carbohydrate Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Daily glucose variability', 'timeFrame': '14 days', 'description': 'Glucose variability will be measured as the coefficient of variation (CV) of glucose levels recorded by continuous glucose monitoring over a 14-day period using a FreeStyle Libre 2 sensor'}, {'measure': 'Beta cell function', 'timeFrame': '12 weeks', 'description': 'Beta cell function will be measured as the beta cell glucose sensitivity obtained from mathematical modeling of plasma glucose and C-peptide levels in response to a 180-minute mixed meal tolerance test (MMTT)'}], 'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '12 weeks', 'description': 'Change in plasma levels of glycated hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Glucose tolerance', 'timeFrame': '12 weeks', 'description': 'Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute mixed meal tolerance test (MMTT)'}, {'measure': 'Body weight loss', 'timeFrame': '12 weeks', 'description': 'Change in body weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Obesity', 'Nutrition, Healthy', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '37971503', 'type': 'DERIVED', 'citation': 'Trico D, Masoni MC, Baldi S, Cimbalo N, Sacchetta L, Scozzaro MT, Nesti G, Mengozzi A, Nesti L, Chiriaco M, Natali A. Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. Diabetologia. 2024 Feb;67(2):263-274. doi: 10.1007/s00125-023-06045-9. Epub 2023 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-75 years\n* both males and females\n* type 2 diabetes\n\nExclusion Criteria:\n\n* type 1 diabetes\n* insulin treatment\n* pharmacological treatment for weight loss\n* pregnancy\n* other acute or chronic conditions influencing body weight and glucose metabolism'}, 'identificationModule': {'nctId': 'NCT05713058', 'briefTitle': 'Metabolic Effects of Early Time-restricted Carbohydrate Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Pisana'}, 'officialTitle': 'Effects of Early Time-restricted Carbohydrate Consumption on Weight Loss and Glucose Homeostasis in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'eTRC DIET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eTRC diet', 'interventionNames': ['Behavioral: eTRC diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control diet', 'interventionNames': ['Behavioral: Control diet']}], 'interventions': [{'name': 'eTRC diet', 'type': 'BEHAVIORAL', 'description': '12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) focusing on the distribution of macronutrients within the day so as to avoid carbohydrate consumption after lunch', 'armGroupLabels': ['eTRC diet']}, {'name': 'Control diet', 'type': 'BEHAVIORAL', 'description': '12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day', 'armGroupLabels': ['Control diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56127', 'city': 'Pisa', 'state': 'PI', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'Andrea Natali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pisa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be shared with other researchers only upon reasonable request to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Nutrition', 'investigatorFullName': 'Andrea Natali', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Pisana'}}}}