Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05717127
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2023-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BMI', 'timeFrame': 'at week 16', 'description': 'Difference in change in BMI between each intervention period'}, {'measure': 'Waist circumference', 'timeFrame': 'at week 16', 'description': 'Difference in change in waist circumference between each intervention period'}, {'measure': 'Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA)', 'timeFrame': 'at week 16', 'description': 'Difference in change in central abdominal mass between each intervention period'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'at week 16', 'description': 'Difference in insulin sensitivity measured by the Matsuda Index between each intervention period'}, {'measure': 'Satiety', 'timeFrame': 'at week 16', 'description': 'Difference in hunger assessed by Visual Analogue Scales (0 to 10mm with increased values associated with increased hunger) between each intervention period'}], 'primaryOutcomes': [{'measure': 'Pancreatic beta-cell function', 'timeFrame': 'at week 16', 'description': 'The difference in percentage change in beta-cell function between each intervention period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': 'at week 16', 'description': 'Difference in change in fasting glucose between each intervention period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '39193706', 'type': 'BACKGROUND', 'citation': 'Kramer CK, Zinman B, Feig DS, Retnakaran R. Effect of Time-Restricted Eating on beta-Cell Function in Adults With Type 2 Diabetes. J Clin Endocrinol Metab. 2025 May 19;110(6):e2045-e2053. doi: 10.1210/clinem/dgae594.'}]}, 'descriptionModule': {'briefSummary': "One known cause of type 2 diabetes (T2DM) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. Unfortunately, no anti-diabetic medication or lifestyle intervention has been shown to prevent the worsening of beta-cell function over time. Interestingly, however, intermittent fasting (IF) - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with T2DM, it is also been shown to improve glycemic control (i.e. reduce the sugar levels). While no research has studied whether IF can improve pancreatic beta-cell function, the positive metabolic effects suggest that it could provide some benefit. The current study will evaluate whether IF can improve pancreatic beta-cell function in individuals with early T2DM."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women with type 2 diabetes mellitus diagnosed within preceding 10 years\n* Age 20-70 years inclusive\n* Body mass index ≥ 25 kg/m2\n* Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination\n* HbA1c value of 5.5 - 9.0% inclusive\n\nExclusion Criteria:\n\n* Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) and/or sulfonylureas\n* Involvements in any other clinical study on lifestyle intervention or requiring drug therapy\n* Any history or eating disorder\n* Renal dysfunction as evidenced by estimated glomerular filtration rate \\<45 mL/min by Modification of Diet in Renal Disease (MDRD) formula\n* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \\>2.5x the upper limit of normal\n* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)\n* Any other factor likely to limit adherence to the study, in the opinion of the investigators'}, 'identificationModule': {'nctId': 'NCT05717127', 'briefTitle': 'Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes', 'orgStudyIdInfo': {'id': '19-0299-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent fasting (time restricted feeding)', 'description': 'Intermittent fasting (IF) study arm consisting of time restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).', 'interventionNames': ['Behavioral: Time restricted feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard lifestyle', 'description': 'Standard lifestyle recommendation as per the Diabetes Canada guidelines, where participants are encouraged to maintain regularity in timing and spacing of means with no specific recommendations regarding the hours of fasting', 'interventionNames': ['Behavioral: Standard lifestyle']}], 'interventions': [{'name': 'Time restricted feeding', 'type': 'BEHAVIORAL', 'description': 'Restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).', 'armGroupLabels': ['Intermittent fasting (time restricted feeding)']}, {'name': 'Standard lifestyle', 'type': 'BEHAVIORAL', 'description': 'Standard lifestyle recommendations', 'armGroupLabels': ['Standard lifestyle']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Endocrinologist and Clinician-scientist', 'investigatorFullName': 'Caroline Kramer', 'investigatorAffiliation': 'Mount Sinai Hospital, Canada'}}}}