Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT00259233
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Peptide YY (PYY)in Inhibiting Food Intake.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2005-11-25', 'studyFirstSubmitQcDate': '2005-11-25', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'appetite'}, {'measure': 'energy intake'}], 'secondaryOutcomes': [{'measure': 'Plasma PYY profile'}, {'measure': 'Blood pressure'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses PYY3-36 on 5 different test days within one week. The patients will be tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum energy intake, blood pressure and blood sampling will be performed during the test day.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal weight (BMI: 18-23 kg/m2) or 12 overweight/obese (BMI: 27-40 kg/m2)\n* Body weight fluctuations \\< 5 kg over the past 2 months.\n* Blood pressure normal to mildly hypertensive(\\<159/99 mm Hg)\n* Non-elite athletes and not planning to change physical activity during the study.\n\nExclusion Criteria:\n\n* Any physiological or psychological illnesses that could influence the study results.\n* Regular use of medicine.\n* Smoking defined as \\<1 cigarette per day.\n* Substance abuse or dependence.\n* Blood donation within the past 3 months before entering the study.\n* Drinking \\>21 alcoholic units/week.\n* Food allergies.\n* Special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.'}, 'identificationModule': {'nctId': 'NCT00259233', 'briefTitle': 'The Role of Peptide YY (PYY)in Inhibiting Food Intake.', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effects of Peripheral Administration of Saline, PYY1-36 and PYY3-36 on ad Libitum Energy Intake and Appetite.', 'orgStudyIdInfo': {'id': 'B208, 2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'peripheral Peptide YY administration', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arne Astrup, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition, RVAU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aditech Pharma AB', 'class': 'INDUSTRY'}]}}}