Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-05 @ 9:07 AM
Study NCT ID:
NCT03047668
Status:
UNKNOWN
Last Update Posted:
2020-07-22
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in 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': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}, {'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': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive 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'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in insulin secretion (glucagon stimulation test)', 'timeFrame': '49 weeks', 'description': 'change in insulin secretion (glucagon stimulation test)'}, {'measure': 'change in hepatic fat content (MR-S)', 'timeFrame': '49 weeks', 'description': 'change in hepatic fat content (MR-S)'}, {'measure': 'change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter', 'timeFrame': '49 weeks', 'description': 'change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter'}, {'measure': 'change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter', 'timeFrame': '49 weeks', 'description': 'change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter'}, {'measure': 'change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter', 'timeFrame': '49 weeks', 'description': 'change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter'}], 'secondaryOutcomes': [{'measure': 'inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)', 'timeFrame': '49 weeks', 'description': 'inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)'}, {'measure': 'change in parameters of peripheral neuropathy - vibration threshold', 'timeFrame': '49 weeks', 'description': 'change in parameters of peripheral neuropathy - vibration threshold'}, {'measure': 'change in parameters of peripheral neuropathy - thermal sensitivity', 'timeFrame': '49 weeks', 'description': 'change in parameters of peripheral neuropathy - thermal sensitivity'}, {'measure': 'change in parameters of peripheral neuropathy - pain thresholds', 'timeFrame': '49 weeks', 'description': 'change in parameters of peripheral neuropathy - pain thresholds'}, {'measure': 'change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)', 'timeFrame': '49 weeks', 'description': 'change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)'}, {'measure': 'change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)', 'timeFrame': '49 weeks', 'description': 'change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'NAFLD', 'Obesity', 'Dyslipidemia', 'Hypertension', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.\n\nThe researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).\n\nPOLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.', 'detailedDescription': 'Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.\n\nThe researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).\n\nPOLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female subjects\n* 18-79 years old\n* type 2 diabetes\n\nExclusion Criteria:\n\n* renal insufficiency\n* anaemia\n* immunosuppression\n* previous symptomatic cancer diagnosis\n* acute cardiovascular disease (stroke, coronary syndrome)\n* pregnancy and lactation\n* severe psychiatric disorders\n* corticoid or other immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT03047668', 'acronym': 'POLYPHEM', 'briefTitle': 'POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'German Institute of Human Nutrition'}, 'officialTitle': 'POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'POLYPHEM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'low-carb with PUFA', 'description': '49 weeks of hypo- to isocaloric low-carb diet (\\< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins', 'interventionNames': ['Dietary Supplement: diet with/without supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low-carb without PUFA', 'description': '49 weeks of hypo- to isocaloric low-carb diet (\\< 40 EI% carbs), without walnuts / walnut-sunflower muffins', 'interventionNames': ['Dietary Supplement: diet with/without supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low-fat with PUFA', 'description': '49 weeks of hypo- to isocaloric low-fat diet (\\< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins', 'interventionNames': ['Dietary Supplement: diet with/without supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low-fat without PUFA', 'description': '49 weeks of hypo- to isocaloric low-fat diet (\\< 30 EI% fat), without walnuts / walnut-sunflower muffins', 'interventionNames': ['Dietary Supplement: diet with/without supplementation']}], 'interventions': [{'name': 'diet with/without supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'diet with/without supplementation with PUFAs', 'armGroupLabels': ['low-carb with PUFA', 'low-carb without PUFA', 'low-fat with PUFA', 'low-fat without PUFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Kabisch, Dr. med.', 'role': 'CONTACT', 'email': 'stefan.kabisch@dife.de', 'phone': '030 450 514 429'}], 'facility': 'DIfE (German Institute for Human Nutrition)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Stefan Kabisch, Dr. med.', 'role': 'CONTACT', 'email': 'stefan.kabisch@dife.de', 'phone': '030 450 514 429'}, {'name': 'June Inderthal', 'role': 'CONTACT', 'email': 'june.inderthal@dife.de', 'phone': '033200 88 2771'}], 'overallOfficials': [{'name': 'Andreas FH Pfeiffer, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DIfE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Institute of Human Nutrition', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Center for Diabetes Research', 'class': 'OTHER'}, {'name': 'California Walnut Commission', 'class': 'OTHER'}, {'name': 'Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Prof. Dr. med. Andreas F. H. Pfeiffer', 'investigatorAffiliation': 'German Institute of Human Nutrition'}}}}