Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-05 @ 5:41 AM
Study NCT ID:
NCT03564002
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2018-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015223', 'term': 'Wolman Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D015217', 'term': 'Cholesterol Ester Storage Disease'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2018-05-26', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lysosomal acid lipase activity', 'timeFrame': 'change from baseline after 25 days', 'description': 'LAL-activity was dosed with dried blood spot (DBS) technique using the inhibitors Lalistat 2'}, {'measure': 'endothelial function', 'timeFrame': 'change from baseline after 25 days', 'description': 'flow mediated dilation at brachial artery by ultrasonography'}, {'measure': 'visceral fat', 'timeFrame': 'change from baseline after 25 days', 'description': 'ultrasonography'}, {'measure': 'liver steatosis', 'timeFrame': 'change from baseline after 25 days', 'description': 'ultrasonography'}, {'measure': 'lipid assessment', 'timeFrame': 'change from baseline after 25 days', 'description': 'total cholesterol, triglycerides, HDL, LDL'}, {'measure': 'general adiposity assessment', 'timeFrame': 'change from baseline after 25 days', 'description': 'bioimpedentiometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lysosomal Acid Lipase Deficiency', 'Obesity', 'Ketogenic Dieting', 'Ketosis']}, 'descriptionModule': {'briefSummary': 'The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. The aim of our study is to evaluate VLCKD impact on metabolic/vascular parameters and LAL activity in obese patients.\n\nA VLCKD is administered for 25 days to 52 morbid obese patients (BMI 44.7±8.3 kg/m², age 49±12.5 years); at baseline and after diet we evaluated: BMI, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (FMD). In a subgroup of 20 patients we also tested lysosomal acid lipase (LAL)-activity. A group of healthy normal weight subjects (age 43±13, BMI 22.8±2.6 kg/m²) was also included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'obese patients referred to our Clinic in order to assess and treat obesity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 40 Kg/m2 or \\> 35 kg/m2 with comorbidities\n\nExclusion Criteria:\n\n* Type-2 diabetes\n* Kidney, heart or liver failure'}, 'identificationModule': {'nctId': 'NCT03564002', 'briefTitle': 'Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity', 'orgStudyIdInfo': {'id': '2017-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'obese subjects'}, {'label': 'lean subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06132', 'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Graziana Lupattelli, Prof', 'role': 'CONTACT', 'email': 'graziana.lupattelli@unipg.it', 'phone': '+390755784023'}], 'facility': 'University of Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}], 'centralContacts': [{'name': 'Graziana Lupattelli, Professor', 'role': 'CONTACT', 'email': 'graziana.lupattelli@unipg.it', 'phone': '+390755784023'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Anastasia Ricci', 'investigatorAffiliation': 'University Of Perugia'}}}}