Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-05 @ 1:33 PM
Study NCT ID:
NCT02674893
Status:
TERMINATED
Last Update Posted:
2019-09-06
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Victoza on Dietary Preferences and Habit in Patients 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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'Exploratory protocol, convincing results, robust analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modifications in wanting', 'timeFrame': 'Up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Modifications in gustatory performance', 'timeFrame': 'Until 3 months'}, {'measure': 'Modifications in liking', 'timeFrame': 'Until 3 months'}, {'measure': 'Modifications in salivation following the presentation of foods', 'timeFrame': 'Until 3 months'}, {'measure': 'Modifications in optimal preferences for sweet and fatty tastes', 'timeFrame': 'Until 3 months'}, {'measure': 'Anthropometric modifications', 'timeFrame': 'Until 3 months'}]}, 'conditionsModule': {'keywords': ['BMI>27', 'Treatment with Liraglutide'], 'conditions': ['Type 2 Diabetes', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '31405666', 'type': 'DERIVED', 'citation': 'Brindisi MC, Brondel L, Meillon S, Barthet S, Grall S, Fenech C, Lienard F, Schlich P, Astruc K, Mouillot T, Jacquin-Piques A, Leloup C, Verges B, Penicaud L. Proof of concept: Effect of GLP-1 agonist on food hedonic responses and taste sensitivity in poor controlled type 2 diabetic patients. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2489-2494. doi: 10.1016/j.dsx.2019.06.021. Epub 2019 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research.\n\nDistribution in groups\n\n* 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1)\n* 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2)\n* 30 healthy subjects (non-diabetics) (group 3)\n\nThis study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDIABETIC PATIENTS TREATED WITH LIRAGLUTIDE\n\n* persons who have provided written informed consent\n* aged \\> 18 years\n* type 2 diabetes with HbA1C \\> 7%\n* overweight (BMI \\> 27)\n* normal renal function (creatinine clearance \\> 50ml/min)\n* patients to be treated with Liraglutide (patients with type 2 diabetes with HbA1C \\> 7.5% and overweight or obesity, whose current treatment is insufficient to control the diabetes).\n\nCONTROL DIABETIC PATIENTS\n\n* persons who have provided written informed consent\n* aged \\> 18 years\n* type 2 diabetes with HbA1C \\> 7%\n* overweight (BMI \\> 27)\n* patients for whom treatment with Liraglutide is not indicated\n* normal renal function (creatinine clearance \\> 50ml/min)\n\nHEALTHY SUBJECTS\n\n* persons who have provided written informed consent\n* aged \\> 18 years\n\nExclusion Criteria:\n\nDIABETIC PATIENTS TREATED WITH LIRAGLUTIDE\n\n* type 1 diabetes\n* decompensated congestive heart failure\n* acute or chronic infection, progressive cancer, liver cirrhosis\n* ongoing treatment with antibiotics\n* smoking\n* chronic alcohol abuse (\\>4 glasses a day)\n* aversion to the products to be eaten or smelled\n* poor understanding of the cognitive tasks requested\n* treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs\n* persons without national health insurance cover\n* persons under guardianship\n* hypersensitivity to Liraglutide\n* pregnancy, breastfeeding\n* history of acute or chronic pancreatitis\n* calcitonin level at selection ≥ 50 ng/L\n* liver disease, defined by a level of alanine aminotransferase (ALAT) ≥ 2.5 times the upper limit of normal (ULN) for reference values\n\nCONTROL DIABETIC PATIENTS\n\n* type 1 diabetes,\n* decompensated congestive heart failure,\n* acute or chronic infection, progressive cancer, liver cirrhosis,\n* ongoing treatment with antibiotics,\n* smoking\n* chronic alcohol abuse (\\> 4 glasses a day),\n* aversion to the products to be eaten or smelled,\n* poor understanding of the cognitive tasks requested,\n* treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs.\n* persons without national health insurance cover\n* persons under guardianship\n\nHEALTHY SUBJECTS\n\n* diabetes (type I and II)\n* sensory disorders\n* decompensated congestive heart failure,\n* acute or chronic infection, progressive cancer, liver cirrhosis,\n* ongoing treatment with antibiotics,\n* smoking\n* chronic alcohol abuse (\\> 4 glasses a day),\n* aversion to the products to be eaten or smelled,\n* poor understanding of the cognitive tasks requested,\n* treatment interfering with olfactogustatory performance (psychotropic, anti-emetic, anti-ulcer drugs)\n* persons without national health insurance cover\n* persons under guardianship\n* contra-indications to MRI, notably, but not limited to: pace maker, implantable cardiac defibrillators, neurostimulators, cochlear implants, certain implanted automated injection systems (insulin pumps), vascular intracerebral ferromagnetic clips, certain systems to regulate intravascular temperature, myopia requiring the patients to wear spectacle, history of stroke or transient ischemic attack (TIA), metallic foreign body, in particular intraocular or situated near high-risk zones (nervous system, vascular system), claustrophobia….'}, 'identificationModule': {'nctId': 'NCT02674893', 'acronym': 'GLP1 et Goût', 'briefTitle': 'Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BRINDISI 2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'type 2 diabetics treated with GLP1 analogue', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Type 2 diabetics not treated with incretins', 'interventionNames': ['Other: Observation alone']}, {'type': 'OTHER', 'label': 'Healthy subjects', 'interventionNames': ['Other: Observation alone']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'armGroupLabels': ['type 2 diabetics treated with GLP1 analogue']}, {'name': 'Observation alone', 'type': 'OTHER', 'armGroupLabels': ['Healthy subjects', 'Type 2 diabetics not treated with incretins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de DIJON', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}