Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT06193668
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2022-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Overfeeding Induced Fat-tissue Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-body insulin sensitivity and WAT insulin sensitivity', 'timeFrame': '3 weeks intervention period each', 'description': 'Hyperinsulinemica-euglycemia clamp tests with deuterated glucose to measure fasting and insulin-stimulated whole-body insulin sensitivity and measurement of the index ADIPO-IR (fasting insulin x free fatty acid concentration) before and after dietary intervention period.'}], 'secondaryOutcomes': [{'measure': 'WAT insulin signaling pathways', 'timeFrame': '3 weeks intervention time', 'description': 'Adipose tissue biopsies are planned to be taken during the fasting and insulin-stimulated state before and after the dietary intervention period. DAG and ceramide subcellular fractionation assay is planned to be performed. Expressionanalyses for activation /membrane translocation of novel and atypical protein kinase C isoforms will be done. Determination of the degree of phosphorylation of various components of the insulin pathway via Western blot are planned.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lipid-induced Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. A key factor in its development is chronic overnutrition, usually with a high-fat diet (HFD), leading to disturbances of glucose and lipid metabolism. However, the mechanism of short-term HFD-induced tissue-specific insulin resistance remains poorly understood. This project aims to further unravel the underlying mechanisms of short-term HFD overnutrition-mediated WAT insulin resistance. The model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. Based on recent studies, the hypothesis is that 21-day hypercaloric HFD induces WAT insulin resistance via a diacylglycerol, novel protein kinase C-insulin receptor signaling model in both fasting and insulin-stimulated states.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 40 years\n* BMI \\< 29 kg/m2\n* Sport inactive (\\<1x /week)\n* Capacity to consent\n\nExclusion Criteria:\n\n* Diabetes mellitus disease\n* Acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation)\n* Acute infectious disease\n* Taking blood glucose-lowering drugs\n* Diseases or drugs affecting the immune system and allergies to drugs used in the study\n* Drugs with potential metabolic effects\n* Chronic liver disease (hepatitis, gallbladder disease, elevated liver enzymes (ALT \\> 300 U/L))\n* Chronic inflammatory bowel diseases\n* Rheumatic diseases\n* Hyper- or hypothyroidism of the thyroid gland\n* Renal insufficiency, administration of iodine-containing contrast media in the last 2 days\n* Chronic lung diseases\n* cancerous diseases\n* Addictive diseases, psychiatric diseases\n* Pregnancy, breastfeeding\n* Shift workers\n* Anemia (Hb \\<12 g/dl)\n* Disorders of hemostasis\n* Regular use of antithrombotic drugs\n* Alcohol consumption, smoking\n* Conditions that do not permit an MRI examination'}, 'identificationModule': {'nctId': 'NCT06193668', 'acronym': 'OVID_FASTI', 'briefTitle': 'Overfeeding Induced Fat-tissue Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'Short-term High-fat Overnutrition Induces Insulin Resistance in White Adipose Tissue', 'orgStudyIdInfo': {'id': 'OVID-FASTI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-fat overnutrition', 'description': 'Lipid overnutrition: 40% higher lipid consumption per day than required over three weeks.', 'interventionNames': ['Behavioral: High-fat overnutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normocaloric macronutrient-balanced nutrition', 'description': 'Normocaloric, macronutrient-balanced nutrition per day over three weeks', 'interventionNames': ['Behavioral: Normocaloric macronutrient-balanced nutrition']}], 'interventions': [{'name': 'High-fat overnutrition', 'type': 'BEHAVIORAL', 'description': 'Overnutrition: 40% higher lipid consumption per day than required', 'armGroupLabels': ['High-fat overnutrition']}, {'name': 'Normocaloric macronutrient-balanced nutrition', 'type': 'BEHAVIORAL', 'description': 'Normocaloric, macronutrient-balanced nutrition:\n\nCalories requirement for weight maintenance \\[(kcal/d) 55% carbohydrates, 15% proteins, 30% fat\\]', 'armGroupLabels': ['Normocaloric macronutrient-balanced nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georgia Xourafa, MD', 'role': 'CONTACT', 'email': 'georgia.xourafa@ddz.de', 'phone': '+492113382426'}, {'name': 'Theresia Sarabhai, MD', 'role': 'CONTACT', 'email': 'theresia.Sarabhai@ddz.de', 'phone': '0211-3382-0'}], 'facility': 'Georgia Xourafa', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Theresia Sarabhai, MD', 'role': 'CONTACT', 'email': 'theresia.sarabhai@ddz.de', 'phone': '0173-9473478', 'phoneExt': 'DDZ'}, {'name': 'Sabine Kahl, MD', 'role': 'CONTACT', 'email': 'sabine.kahl@ddz.de', 'phone': '0221-3382-', 'phoneExt': '698'}], 'overallOfficials': [{'name': 'Michael Roden, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'German Diabetes Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}