Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT06144593
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With 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': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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': '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': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Dietary intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Explorative outcomes - Questionnaires on quality of life', 'timeFrame': 'day 30', 'description': "Participants will complete the questionnaires 'Problem Areas In Diabetes' \\& 'World Health Organisation-Five Well-Being Index'."}, {'measure': 'Explorative outcomes - Qualitative evaluation to assess feasibility of the dietary strategy', 'timeFrame': 'day 30', 'description': 'A semi-structured evaluation interview to assess social context, eating practices, compliance to, and feasibility and acceptability of the intermittent carbohydrate restriction regime will be carried out.'}], 'primaryOutcomes': [{'measure': '24-hour average sensor glucose', 'timeFrame': '24-hour average sensor glucose is measured as the average of eight consecutive days (starting from two days post sensor mounting) from the intermittent carbohydrate restriction period and the corresponding days of the control period (i.e. days 17-24).', 'description': 'A patient-blinded continuous glucose monitoring (CGM) is worn during the last two weeks of both the intervention and control period.'}], 'secondaryOutcomes': [{'measure': 'Liver triacylglycerol content', 'timeFrame': 'day 30 adjusted for baseline', 'description': 'Liver TG content will be measured by 1H-Magnetic Resonance Spectroscopy (MRS) on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30).'}, {'measure': 'Fasting plasma concentrations of triacylglycerols', 'timeFrame': 'day 30 adjusted for baseline', 'description': 'Fasting plasma concentrations of triacylglycerols measured on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Overweight and Obesity', 'Non-Alcoholic Fatty Liver Disease', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women\n* 35-75 years old\n* BMI \\>27 kg/m2\n* Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c \\>48 mmol/mol if no glucose lowering therapy\n\nExclusion Criteria:\n\n* Anemia (hemoglobin \\<8 mmol/L for men and \\<7 mmol/L for women)\n* TSH outside reference range\n* Treatment with insulin, sulfonylurea, or SGLT2-inhibitors\n* Treatment with systemic corticosteroids\n* HbA1c \\>70 mmol/mol\n* eGFR \\<60 ml/min/1.73 m2\n* Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia\n* Food allergies (including lactose and gluten intolerance)\n* Vegetarian/vegan diet or following of specific dietary plans\n* Alcohol consumptions \\>84/168 g/week (women/men)\n* Strenuous activity level \\> 120 minutes per week\n* Weight loss (\\>5 kg) within the last three months or previous bariatric surgery\n* High risk of fibrosis of the liver (estimated by FIB4 score \\> 3.25)'}, 'identificationModule': {'nctId': 'NCT06144593', 'acronym': 'INTERCARB', 'briefTitle': 'The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'INTERCARB - H-23043085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent carbohydrate restriction', 'description': 'Four weeks of intermittent carbohydrate restriction: a dietary regime alternating between two days of restricting carbohydrate intake to 70-90 grams, while energy intake is ad libitum, from fat- and protein-containing foods, and two days of non-restricted diet.', 'interventionNames': ['Other: Dietary macronutrient composition']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Four weeks of free-living with no dietary restrictions.'}], 'interventions': [{'name': 'Dietary macronutrient composition', 'type': 'OTHER', 'description': 'Intermittent carbohydrate restriction', 'armGroupLabels': ['Intermittent carbohydrate restriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kirstine Nyvold Bojsen-Møller, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Department of Endocrinology, Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Amanda Schaufuss, MSc', 'role': 'CONTACT', 'email': 'amanda.schaufuss@regionh.dk', 'phone': '+4530270261'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Danish Research Centre for Magnetic Resonance', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor', 'investigatorFullName': 'Kirstine Nyvold Bojsen-Moeller', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}