Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-28 @ 11:42 AM
Study NCT ID:
NCT01224561
Status:
COMPLETED
Last Update Posted:
2011-05-05
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013851', 'term': 'Thinness'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'muscle tissue fat tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-04', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gene expression', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues'}], 'secondaryOutcomes': [{'measure': 'Anthropometric parameter', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Lean mass'}, {'measure': 'Autonomic nervous system activity', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Heart rate variability analyses using ECG Holter monitoring'}, {'measure': 'gastrointestinal hormone level', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Serum level of GLP1'}, {'measure': 'Anthropometric parameter', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Weight'}, {'measure': 'Anthropometric parameter', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Fat mass'}, {'measure': 'gastrointestinal hormone level', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Serum level of ghréline'}, {'measure': 'gastrointestinal hormone level', 'timeFrame': 'After one month of lipid overnutrition', 'description': 'Serum level of PYY'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thinness', 'Leanness', 'healthy volunteers', 'Lipid metabolism disorder'], 'conditions': ['Lipid Overnutrition', 'Constitutional Thinness']}, 'descriptionModule': {'briefSummary': 'For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or in obese patients by promoting weight gain, either in constitutional thinness (MC) by blocking it. The MC is a little known entity. These patients wish to grow for her and others. Can they? We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY, GLP1 and leptin) that may participate in thinness. Furthermore, this thinness is associated with osteoporosis in 25% of true MC who is 25 years old.', 'detailedDescription': 'This project aims to overfed MCs and follow the control parameters of energy metabolism. We will look for abnormalities in the adaptation to overnutrition in subjects with genetic background of thinness, which could explain the resistance to weight gain. The answer could possibly help to understand obesity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Constitutionnal thinness women and healthy volonteers(women)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consent form the study signed\n* consent form for genetic study signed\n* normal laboratory values for liver enzymes, glucose, lipid\n\nExclusion Criteria (common to the two groups):\n\n* pregnant\n* vegetarian\n* heavy smoking\n* heavy alcohol\n* depressive\n* taking hypolipidemic or antihypertensive drugs\n* dyslipidemia'}, 'identificationModule': {'nctId': 'NCT01224561', 'acronym': 'Surnutrition', 'briefTitle': 'Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness', 'orgStudyIdInfo': {'id': '0701047'}, 'secondaryIdInfos': [{'id': '2007-A00744-49', 'type': 'OTHER', 'domain': 'Afssaps'}, {'id': 'DGS2007-0536', 'type': 'OTHER', 'domain': 'DGS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Constitutional thinness', 'description': 'Women with a a body mass index of less than 16.5 kg/m2', 'interventionNames': ['Behavioral: Lipid overnutrition']}, {'label': 'Healthy Volonteer', 'description': 'Women with a body mass index between 20 and 25 kg/m2', 'interventionNames': ['Behavioral: Lipid overnutrition']}], 'interventions': [{'name': 'Lipid overnutrition', 'type': 'BEHAVIORAL', 'description': 'During 4 months, the daily caloric intake will be increased by about 70 g fat as butter 20 grams, 100 grams of cheese (Emmental) and 40 grams of almonds. This overnutrition corresponds to an excess of 760 kcal / day or 21,280 calories for the period and then taken to a theoretical 2.4 kg of fat (1 kg fat = 9000 kcal).', 'armGroupLabels': ['Constitutional thinness', 'Healthy Volonteer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CRNH Auvergne', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'CRNH Rhône-Alpes', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Bruno ESTOUR, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Clément CAILLAUX', 'oldOrganization': 'Centre Hospitalier Universitaire de Saint-Etienne'}}}}