Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04283318
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2019-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-23', 'releaseDate': '2023-07-06'}, {'resetDate': '2024-09-18', 'releaseDate': '2024-04-29'}, {'resetDate': '2025-01-10', 'releaseDate': '2024-11-21'}], 'estimatedResultsFirstSubmitDate': '2023-07-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D013217', 'term': 'Starvation'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of 2h glucose levels', 'timeFrame': 'after 12 and 36 hours of fasting', 'description': 'Difference in the change of 2h glucose levels in an oral glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'changes in insulin sensitivity (QUICKI)', 'timeFrame': 'after 12 and 36 hours of fasting', 'description': 'differences in QUICKI'}, {'measure': 'changes in insulin sensitivity (Matsuda Index)', 'timeFrame': 'after 12 and 36 hours of fasting', 'description': 'differences in Matsuda Index'}, {'measure': 'changes in insulin sensitivity (ISI)', 'timeFrame': 'after 12 and 36 hours of fasting', 'description': 'differences in ISI'}, {'measure': 'changes in insulin sensitivity (HOMA-Index)', 'timeFrame': 'after 12 and 36 hours of fasting', 'description': 'differences in HOMA-Index'}, {'measure': 'Changes in glycaemic pattern', 'timeFrame': 'after 12 and 36 hours of fasting', 'description': 'differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test'}, {'measure': 'Changes in body composition', 'timeFrame': 'after 12 and 36 hours of fasting', 'description': 'differences in bioimpedance analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['starvation', 'healthy people', 'obese', 'Type 2 diabetes mellitus', 'glucose metabolism', 'Type 1 diabetes mellitus'], 'conditions': ['Healthy', 'Obesity', 'Type 2 Diabetes Mellitus', 'Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'In a previous study investigating the effects of intermittent fasting, our research group found evidence for higher glucose excursions and a reduced insulin response after a 36 hour fasting period as compared to an overnight fasting period in healthy subjects.\n\nThe aim of this research project is to investigate the effect of short and midterm fasting (12 hours versus 36 hours) on glucose metabolism, glucose regulatory hormones, insulin secretion and resting energy expenditure in healthy and obese people as well as in patients with type 2 diabetes.', 'detailedDescription': 'In this clinical study, we want to examine the effects of different fasting periods (12 hours versus 36 hours) on blood sugar levels and other metabolic parameters and hormones. For this the following investigations are carried out:\n\n* Oral glucose tolerance test with detailed laboratory evaluation\n* Bio-impedance measurement to determine body composition (muscle and fat mass)\n\nThe examinations are carried out on 4 different cohorts (normal healthy persons, obese patients, patients with type 2 diabetes and patients with type 1 diabetes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Gender: Both, male and female Minimum Age: 18 years\n\nInclusion Criteria Cohort I (Healthy, non-obese subjects) Age \\>18 years; body mass index in the range of 20.0-27.0 kg/m2; fasting plasma glucose \\<110mg/dL\n\nInclusion criteria cohort II (Obese subjects) Age \\>18 years; body mass index \\>30 kg/m2; fasting plasma glucose \\<110mg/dL\n\nInclusion Criteria Cohort III (Cohort with subjects with Type 2 Diabetes Mellitus) Age \\>18 years; established Diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, Dipeptidylpeptidase (DPP)-4-inhibitors or sulfonylurea\n\nInclusion Criteria Cohort IV (Cohort with subjects with Type 1 Diabetes Mellitus) Age \\>18 years; diagnosed with Type 1 Diabetes Mellitus \\>12 months; treated with multiple daily Insulin injectioins (MDII) or continuous subcutaneous Insulin Infusion (CSII); stable Insulin therapy as clinically assessed by the study physician; C-Peptide negative defined as 0.3 nmol/L; HbA1c \\<9.5%; no diabetic ketoacidosis within the last 12 months; no severe hypoglycaemia requiring external assistance within the last 12 months; running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous Glucose Monitoring System (iCGM) as Standard of care for Glucose monitoring\n\nExclusion Criteria (for all participants) History of cardiovascular disease; acute or chronic inflammatory disorder; heavy drinking (more than 15 drinks/week); dietary restrictions (e.g. vegetarianism and vegan); insulin Treatment (excluded subjects with Type 1 Diabetes Mellitus); corticosteroid therapy; known malignancy; women who are pregnant, breast-feeding or trying to become pregnant; history of any chronic disease process that could interfere with interpretation of study results; therapy with antidepressants within past 6 months'}, 'identificationModule': {'nctId': 'NCT04283318', 'acronym': 'PROLOG', 'briefTitle': 'Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'The Effects of Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'HS-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy', 'description': 'Age \\>18 years; BMI 20-27 kg/m2; Fasting plasma Glucose \\<110 mg/dL', 'interventionNames': ['Behavioral: 12h fasting', 'Behavioral: 36h fasting']}, {'type': 'OTHER', 'label': 'Obese people', 'description': 'Age \\>18 years; BMI \\>30 kg/m2; Fasting Plasma Glucose \\<110 mg/dL', 'interventionNames': ['Behavioral: 12h fasting', 'Behavioral: 36h fasting']}, {'type': 'OTHER', 'label': 'Type 2 Diabetes', 'description': 'Age \\>18 years; Diagnosed Type 2 Diabetes mellitus (diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea)', 'interventionNames': ['Behavioral: 12h fasting', 'Behavioral: 36h fasting']}, {'type': 'OTHER', 'label': 'Type 1 Diabetes', 'description': 'Age \\>18 years; Diagnosed Type 1 Diabetes mellitus \\>12 months; Treated with multiple daily Insulin injections (MDII) or continuous subcutaneous Insulin Infusion (CSII); Stable Insulin therapy as clinically assessed by the study physician C-Peptide negative defined as 0.3 nmol/L; No diabetic ketoacidosis within the last 12 months; No severe hypoglycaemia requiring external assistance within the last 12 months; Running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous Glucose Monitoring System (iCGM) as Standard of care for Glucose monitoring', 'interventionNames': ['Behavioral: 12h fasting', 'Behavioral: 36h fasting']}], 'interventions': [{'name': '12h fasting', 'type': 'BEHAVIORAL', 'description': '12h fasting (overnight)', 'armGroupLabels': ['Healthy', 'Obese people', 'Type 1 Diabetes', 'Type 2 Diabetes']}, {'name': '36h fasting', 'type': 'BEHAVIORAL', 'description': '36h fasting ( one day and two nights fasting)', 'armGroupLabels': ['Healthy', 'Obese people', 'Type 1 Diabetes', 'Type 2 Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Harald Sourij, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz, Auenbruggerplatz 15'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-07-06', 'type': 'RELEASE'}, {'date': '2024-02-23', 'type': 'RESET'}, {'date': '2024-04-29', 'type': 'RELEASE'}, {'date': '2024-09-18', 'type': 'RESET'}, {'date': '2024-11-21', 'type': 'RELEASE'}, {'date': '2025-01-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Medical University of Graz'}}}}