Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00140205
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2005-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Leptin Administration During Fasting
Sponsor:
Organization:
Raw JSON
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'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.1 mg/kg', 'unitOfMeasure': 'NG*H/ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 LEAN MEN Fed (24h) or Fasting (72 Hrs)'}, {'id': 'OG001', 'title': '5 OBESE MEN Fed (24h) or Fasting (72 Hrs)'}, {'id': 'OG002', 'title': '5 LEAN WOMEN Fed (24h) or Fasting (72 Hrs)'}], 'timeFrame': '1 DAY or DAY 3', 'description': 'Data were collected neither in Fed nor in Fasting state for the different doses of leptin', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 LEAN MEN Fed (24h) or Fasting (72 Hrs)'}, {'id': 'OG001', 'title': '5 OBESE MEN Fed (24h) or Fasting (72 Hrs)'}, {'id': 'OG002', 'title': '5 LEAN WOMEN Fed (24h) or Fasting (72 Hrs)'}], 'timeFrame': '1 DAY or DAY 3', 'description': 'Data were collected neither in Fed nor in Fasting state for the different doses of leptin', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 LEAN MEN Fed (24h) or Fasting (72 Hrs)'}, {'id': 'OG001', 'title': '5 OBESE MEN 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'5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LEAN MEN 24h Fed or 72h Fasting in Different Leptin Doses', 'description': '5 lean men were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)'}, {'id': 'BG001', 'title': 'OBESE MEN 24h Fed or 72h Fasting in Different Leptin Doses', 'description': '5 obese men were fasted for 72 hrs and during that period recieved 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)'}, {'id': 'BG002', 'title': 'OBESE WOMEN 24h Fed or 72h Fasting in Different Leptin Doses', 'description': '5 lean women were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '.09', 'groupId': 'BG000'}, {'value': '23', 'spread': '.08', 'groupId': 'BG001'}, {'value': '22', 'spread': '.05', 'groupId': 'BG002'}, {'value': '23', 'spread': '.07', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'title': 'BMI>30kg/m2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'BMI<25kg/m2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2005-08-30', 'resultsFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-08', 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.01 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.01 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.01 mg/kg'}, {'measure': 'Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.1 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.1 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.1 mg/kg'}, {'measure': 'Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.3 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.3 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg', 'timeFrame': '3 DAY', 'description': '72-hour fasting Day 3 Leptin dose 0.3 mg/kg'}, {'measure': 'Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.3 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.3 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.3 mg/kg'}, {'measure': 'Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.01 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.01 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.01 mg/kg'}, {'measure': 'Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.1 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.1 mg/kg'}, {'measure': 'Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg', 'timeFrame': '1 DAY', 'description': '24-hour fed Leptin dose 0.1 mg/kg'}], 'secondaryOutcomes': [{'measure': 'Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)', 'timeFrame': '1 DAY or DAY 3', 'description': 'Data were collected neither in Fed nor in Fasting state for the different doses of leptin'}, {'measure': 'Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)', 'timeFrame': '1 DAY or DAY 3', 'description': 'Data were collected neither in Fed nor in Fasting state for the different doses of leptin'}, {'measure': 'Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)', 'timeFrame': 'day 3 of fasting and day 1 of fed state', 'description': 'Data were collected neither in Fed nor in Fasting state for the different doses of leptin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['leptin', 'fasting', 'pharmacokinetics'], 'conditions': ['Energy Deficiency Due to Short-term Fasting']}, 'referencesModule': {'references': [{'pmid': '35820631', 'type': 'DERIVED', 'citation': 'Bouzoni E, Perakakis N, Connelly MA, Angelidi AM, Pilitsi E, Farr O, Stefanakis K, Mantzoros CS. PCSK9 and ANGPTL3 levels correlate with hyperlipidemia in HIV-lipoatrophy, are regulated by fasting and are not affected by leptin administered in physiologic or pharmacologic doses. Metabolism. 2022 Sep;134:155265. doi: 10.1016/j.metabol.2022.155265. Epub 2022 Jul 9.'}, {'pmid': '33051459', 'type': 'DERIVED', 'citation': 'Chrysafi P, Perakakis N, Farr OM, Stefanakis K, Peradze N, Sala-Vila A, Mantzoros CS. Leptin alters energy intake and fat mass but not energy expenditure in lean subjects. Nat Commun. 2020 Oct 13;11(1):5145. doi: 10.1038/s41467-020-18885-9.'}, {'pmid': '21917874', 'type': 'DERIVED', 'citation': 'Moragianni VA, Aronis KN, Chamberland JP, Mantzoros CS. Short-term energy deprivation alters activin a and follistatin but not inhibin B levels of lean healthy women in a leptin-independent manner. J Clin Endocrinol Metab. 2011 Dec;96(12):3750-8. doi: 10.1210/jc.2011-1453. Epub 2011 Sep 14.'}, {'pmid': '21660636', 'type': 'DERIVED', 'citation': 'Aronis KN, Diakopoulos KN, Fiorenza CG, Chamberland JP, Mantzoros CS. Leptin administered in physiological or pharmacological doses does not regulate circulating angiogenesis factors in humans. Diabetologia. 2011 Sep;54(9):2358-67. doi: 10.1007/s00125-011-2201-x. Epub 2011 Jun 10.'}, {'pmid': '20703446', 'type': 'DERIVED', 'citation': 'Scheer FA, Chan JL, Fargnoli J, Chamberland J, Arampatzi K, Shea SA, Blackburn GL, Mantzoros CS. Day/night variations of high-molecular-weight adiponectin and lipocalin-2 in healthy men studied under fed and fasted conditions. Diabetologia. 2010 Nov;53(11):2401-5. doi: 10.1007/s00125-010-1869-7. Epub 2010 Aug 12.'}], 'seeAlsoLinks': [{'url': 'http://www.bidmc.org/Research/Departments/Medicine/Divisions/Endocrinology/Laboratories/MantzorosLab.aspx', 'label': 'Click here for more information about the Mantzoros Research Group.'}, {'url': 'http://www.bidmc.org/', 'label': 'Click here for more information about Beth Israel Deaconess Medical Center.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.', 'detailedDescription': 'Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage. Leptin levels usually go down when people are not eating for extended periods of time. Changes in metabolism and certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin administration, we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels. Investigations such as this one have important implications for the future therapeutic use of leptin, including determining the appropriate dose of leptin to use in future studies involving leptin administration.\n\nComparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy men with body mass indices (BMI) \\<25 kg/m2)\n* overweight otherwise healthy men with BMI \\> 27 kg/m2\n* healthy lean women with BMI\\<25 kg/m2\n* overweight otherwise healthy women with BMI \\> 27 kg/m2\n\nExclusion Criteria:\n\n* history of any illness that may affect the concentrations of the hormones that will be studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)\n* on medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti-seizure medications or thyroid hormones)\n* known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. Coli derived proteins\n* women who are breast feeding, pregnant, or wanting to become pregnant during the next 6 months'}, 'identificationModule': {'nctId': 'NCT00140205', 'briefTitle': 'Pharmacokinetics of Leptin Administration During Fasting', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Pharmacokinetics of Leptin Administration During Fasting', 'orgStudyIdInfo': {'id': '2001P000260'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fed state or fasting state', 'description': '1-day fed studies with administration of r-metHuLeptin at three different doses (0.01 mg/kg, 0.1 mg/kg, 0.3 mg/kg). All subjects participated in 3 studies in the fed condition (Part A) and 3 separate 72-hour fasting studies.\n\nIntervention administered was-r-metreleptin in 3 different doses', 'interventionNames': ['Drug: r-metHuLeptin']}], 'interventions': [{'name': 'r-metHuLeptin', 'type': 'DRUG', 'otherNames': ['Recombinant leptin'], 'description': 'r-metreleptin was given in 3 different dose in fed and fasting states', 'armGroupLabels': ['Fed state or fasting state']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Christos S Mantzoros, MD DSc FACP FACE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Christos Mantzoros', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}