Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02472951
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-15', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'Measured during meal tests (2 days with each intervention)', 'description': 'Insulin sensitivity as measured by the oral minimal model applied to the meal test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '36061897', 'type': 'DERIVED', 'citation': 'Thomsen MN, Skytte MJ, Samkani A, Astrup A, Fenger M, Frystyk J, Hartmann B, Holst JJ, Larsen TM, Madsbad S, Magkos F, Rehfeld JF, Haugaard SB, Krarup T. Weight loss improves beta-cell function independently of dietary carbohydrate restriction in people with type 2 diabetes: A 6-week randomized controlled trial. Front Nutr. 2022 Aug 19;9:933118. doi: 10.3389/fnut.2022.933118. eCollection 2022.'}, {'pmid': '32859328', 'type': 'DERIVED', 'citation': 'Thomsen MN, Skytte MJ, Astrup A, Deacon CF, Holst JJ, Madsbad S, Krarup T, Haugaard SB, Samkani A. The clinical effects of a carbohydrate-reduced high-protein diet on glycaemic variability in metformin-treated patients with type 2 diabetes mellitus: A randomised controlled study. Clin Nutr ESPEN. 2020 Oct;39:46-52. doi: 10.1016/j.clnesp.2020.07.002. Epub 2020 Aug 1.'}, {'pmid': '30591062', 'type': 'DERIVED', 'citation': 'Samkani A, Skytte MJ, Anholm C, Astrup A, Deacon CF, Holst JJ, Madsbad S, Boston R, Krarup T, Haugaard SB. The acute effects of dietary carbohydrate reduction on postprandial responses of non-esterified fatty acids and triglycerides: a randomized trial. Lipids Health Dis. 2018 Dec 27;17(1):295. doi: 10.1186/s12944-018-0953-8.'}, {'pmid': '29644957', 'type': 'DERIVED', 'citation': 'Samkani A, Skytte MJ, Kandel D, Kjaer S, Astrup A, Deacon CF, Holst JJ, Madsbad S, Rehfeld JF, Haugaard SB, Krarup T. A carbohydrate-reduced high-protein diet acutely decreases postprandial and diurnal glucose excursions in type 2 diabetes patients. Br J Nutr. 2018 Apr;119(8):910-917. doi: 10.1017/S0007114518000521.'}]}, 'descriptionModule': {'briefSummary': 'Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their insulinotropic effects due to their glucose dependency. This will reduce postprandial insulin concentration, resulting in an improved insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in plasma and novel measures of fatty acid metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men age 18-70 years\n* Postmenopausal women age 55-70 years\n* Non-smoker (abstinent at least 6 months)\n* HbA1c \\< 74 mmol/mol\n* Fasting blood glucose \\< 11 mmol/L (mean of 3 measurements)\n* Negative (\\<25 IU/L) plasma glutamate decarboxylase (GAD-65) antibodies (IgG)\n* Hemoglobin \\> 7.5 mmol/L (men); \\> 6.8 mmol/L (women)\n* Normal thrombocytes (140-400 x 109/L)\n* eGFR \\> 45 ml/min per 1.73 m2\n* Alkaline phosphatase \\< 140 IU/L\n* Alanine aminotransferase \\< 70 IU/L\n* Normal International Normalized Ratio (0.9-1.2)\n\nExclusion Criteria:\n\n* Critical illness\n* Anti-diabetic drugs other than metformin (maximum of 2000 mg / day)\n* Steroid treatment e.g. prednisolone\n* Reported or journalized severe food allergy or intolerance\n* Reported or journalized gut disease e.g. Crohn's disease, Coeliac disease\n* Reported or journalized alcohol dependence syndrome"}, 'identificationModule': {'nctId': 'NCT02472951', 'acronym': 'CutDM', 'briefTitle': 'Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study', 'orgStudyIdInfo': {'id': '46559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Type 2 diabetic subjects', 'interventionNames': ['Other: Low carbohydrate meals', 'Other: Standard carbohydrate meals']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prediabetic subjects', 'interventionNames': ['Other: Low carbohydrate meals', 'Other: Standard carbohydrate meals']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy subjects', 'interventionNames': ['Other: Low carbohydrate meals', 'Other: Standard carbohydrate meals']}], 'interventions': [{'name': 'Low carbohydrate meals', 'type': 'OTHER', 'description': 'Meal macronutritional energy composition:\n\nCarbohydrate 30% Protein 30% Fat 40%', 'armGroupLabels': ['Healthy subjects', 'Prediabetic subjects', 'Type 2 diabetic subjects']}, {'name': 'Standard carbohydrate meals', 'type': 'OTHER', 'description': 'Meal macronutritional energy composition:\n\nCarbohydrate 55% Protein 15% Fat 30%', 'armGroupLabels': ['Healthy subjects', 'Prediabetic subjects', 'Type 2 diabetic subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Endocrinological Dept. Bispebjerg University Hospital'}], 'overallOfficials': [{'name': 'Steen B Haugaard, MD, DMSc, associate prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amager og Hvidovre Hospital'}, {'name': 'Thure Krarup, MD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bispebjerg Hospital'}, {'name': 'Amirsalar Samkani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD-stud', 'investigatorFullName': 'Amirsalar Samkani', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}