Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:44 AM
Study NCT ID:
NCT00940134
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061785', 'term': 'peptide YY (3-36)'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-14', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-14', 'lastUpdatePostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ad libitum energy intake', 'timeFrame': 'Immediately following 3h IV infusion'}], 'secondaryOutcomes': [{'measure': 'Energy expenditure (ventilated hood technique).', 'timeFrame': 'During 3h IV infusion'}, {'measure': 'Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin', 'timeFrame': 'Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion'}, {'measure': 'Appetite sensation by visual analog scale', 'timeFrame': 'Every 30 minutes during 3h IV infusion'}, {'measure': 'Gastric emptying (paracetamol)', 'timeFrame': 'At time=15, 30, 60, 90, 120, 180 mins during IV infusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'energy expenditure', 'incretins', 'appetite regulation', 'GLP-1', 'PYY', 'ad libitum energy intake'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24735885', 'type': 'DERIVED', 'citation': 'Schmidt JB, Gregersen NT, Pedersen SD, Arentoft JL, Ritz C, Schwartz TW, Holst JJ, Astrup A, Sjodin A. Effects of PYY3-36 and GLP-1 on energy intake, energy expenditure, and appetite in overweight men. Am J Physiol Endocrinol Metab. 2014 Jun 1;306(11):E1248-56. doi: 10.1152/ajpendo.00569.2013. Epub 2014 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone alone will decrease food intake at a buffet meal and decrease appetite, and that in combination, there will be a greater decrease in food intake and appetite compared to each hormone alone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men age 18-50 years\n* BMI ≥30\n* healthy\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* psychological illness\n* on special diets (eg vegetarian, Atkins)\n* weight change of \\>3kg within the 2 months prior to screening\n* Hypothalamic or genetic aetiology of obesity\n* diagnosed cancer\n* chronic illness or disease\n* Eating disorder (anorexia or bulimia)\n* smoking\n* substance abuse\n* Use of any prescription or over the counter medication that can affect metabolism\n* Excessive intake of alcohol (\\>7 drinks/week)\n* Excessive intake of caffeine (\\>300 mg/day)\n* High level of physical activity (\\>10 hours/week)\n* Lack of desire or willingness to take part in and follow study protocol'}, 'identificationModule': {'nctId': 'NCT00940134', 'acronym': 'INGEAR-1', 'briefTitle': 'Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'INGEAR-1: Effects of INtravenous Infusions of PYY3-36 and GLP-1, as Monoinfusion and in Combination, on ad Libitum Energy Intake, Appetite Sensation, and Energy Expenditure in Healthy Obese Subjects.', 'orgStudyIdInfo': {'id': 'B262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Study participants will receive a 3 hour IV infusion of saline while fasting.', 'interventionNames': ['Biological: saline infusion']}, {'type': 'EXPERIMENTAL', 'label': 'PYY3-36 + GLP-1', 'description': 'Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.', 'interventionNames': ['Biological: PYY 3-36', 'Biological: GLP-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1', 'description': 'Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.', 'interventionNames': ['Biological: GLP-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PYY3-36', 'description': 'Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.', 'interventionNames': ['Biological: PYY 3-36']}], 'interventions': [{'name': 'PYY 3-36', 'type': 'BIOLOGICAL', 'description': '0.8 pmol/kg/min x 3 hours', 'armGroupLabels': ['PYY3-36', 'PYY3-36 + GLP-1']}, {'name': 'GLP-1', 'type': 'BIOLOGICAL', 'description': '1.0 pmol/kg/min x 3 hours', 'armGroupLabels': ['GLP-1', 'PYY3-36 + GLP-1']}, {'name': 'saline infusion', 'type': 'BIOLOGICAL', 'description': 'saline infusion x 3 hours', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Nikolaj T Gregersen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'AAstrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}