Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT00691158
Status:
UNKNOWN
Last Update Posted:
2022-12-16
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide
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': 'C105254', 'term': 'pramlintide'}, {'id': 'D058228', 'term': 'Islet Amyloid Polypeptide'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D020738', 'term': 'Leptin'}], 'ancestors': [{'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D058227', 'term': 'Amyloidogenic Proteins'}, {'id': 'D000682', 'term': 'Amyloid'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D054392', 'term': 'Adipokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2008-06-02', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.', 'timeFrame': 'over 90 minutes', 'description': 'measurements at each study time are include fMRI, blood draws and Visual Analog Score.'}], 'secondaryOutcomes': [{'measure': 'Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.', 'timeFrame': 'over 90 minutes', 'description': 'Blood samples are taken every 5 minutes from Timepoint +0 to Timepoint +60 and again one time at Timepoint +90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify how certain parts of the brain that help control body weight respond to an infusion of hormones called leptin and amylin.', 'detailedDescription': 'Following an overnight fast, subjects will undergo fMRI measurements of the hypothalamus, brainstem and whole brain during an infusion of either normal saline, pramlintide, leptin, or the combination leptin and pramlintide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 year to 45 years of age\n* MI 18 to 25 kg/m2 or ≥ 30 kg/m2\n* At maximal lifetime weight\n* Weight stable for at least 3 months\n\nExclusion Criteria:\n\n* Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.\n* Subjects taking psychiatric or centrally-acting (CNS) medications or who are diagnosed with a psychiatric or neurological illness, including:\n\n * depression\n * anorexia\n * bulimia\n * seizure disorder.\n* Exercise \\> 30 minutes, 3 times a week\n* Alcohol consumption \\> 2 drinks / day\n* Weight \\> 350 lbs (159 kg) (weight limit for MR machine)\n* Illicit drug use\n* Pregnancy\n* Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate or fat intakes\n* Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips\n* Those with claustrophobia\n* Anaphylaxis and known hypersensitivity to E. coli-derived proteins\n* Allergies or contraindications to metreleptin or pramlintide\n* Renal or hepatic impairment\n* Women who are lactating\n* Tobacco use'}, 'identificationModule': {'nctId': 'NCT00691158', 'briefTitle': 'A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Pilot Study of the fMRI Response to Leptin and Pramlintide', 'orgStudyIdInfo': {'id': 'eIRB #2168'}, 'secondaryIdInfos': [{'id': 'OCTRI #933', 'type': 'OTHER', 'domain': 'Oregon Health and Sciences University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1- Normal Saline', 'description': '4.7 mls normal saline IV bolus', 'interventionNames': ['Drug: Placebo (Normal Saline)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Metreleptin', 'description': 'IV Leptin bolus', 'interventionNames': ['Drug: 2 Metreleptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 Pramlintide', 'description': 'IV Pramlintide bolus at Timpoint +0 and +30 minutes', 'interventionNames': ['Drug: Pramlintide (Amylin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 Leptin plus Pramlintide', 'description': 'leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes', 'interventionNames': ['Drug: Leptin plus Pramlintide']}], 'interventions': [{'name': 'Pramlintide (Amylin)', 'type': 'DRUG', 'otherNames': ['Amylin'], 'description': '4.7 mls of Amylin 15mcg/ml IV bolus.', 'armGroupLabels': ['3 Pramlintide']}, {'name': 'Placebo (Normal Saline)', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '4.7 mls normal saline IV bolus x1', 'armGroupLabels': ['1- Normal Saline']}, {'name': '2 Metreleptin', 'type': 'DRUG', 'otherNames': ['Leptin'], 'description': 'Receive .06mg/kg of metreleptin IV bolus x1', 'armGroupLabels': ['2 Metreleptin']}, {'name': 'Leptin plus Pramlintide', 'type': 'DRUG', 'otherNames': ['Leptin and Amylin'], 'description': 'receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.', 'armGroupLabels': ['4 Leptin plus Pramlintide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Jonathan Q. Purnell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU - Center for the Study of Weight Regulation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jonathan Purnell', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}