Pharmacokinetics of Leptin Administration During Fasting
NCT ID: NCT00140205
Last Updated: 2018-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2001-02-28
2016-12-31
Brief Summary
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Detailed Description
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Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Fed state or fasting state
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.
Intervention administered was-r-metreleptin in 3 different doses
r-metHuLeptin
r-metreleptin was given in 3 different dose in fed and fasting states
Interventions
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r-metHuLeptin
r-metreleptin was given in 3 different dose in fed and fasting states
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* overweight otherwise healthy men with BMI \> 27 kg/m2
* healthy lean women with BMI\<25 kg/m2
* overweight otherwise healthy women with BMI \> 27 kg/m2
Exclusion Criteria
* on medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti-seizure medications or thyroid hormones)
* known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. Coli derived proteins
* women who are breast feeding, pregnant, or wanting to become pregnant during the next 6 months
18 Years
30 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Christos Mantzoros
Professor of Medicine
Principal Investigators
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Christos S Mantzoros, MD DSc FACP FACE
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Click here for more information about the Mantzoros Research Group.
Click here for more information about Beth Israel Deaconess Medical Center.
Other Identifiers
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2001P000260
Identifier Type: -
Identifier Source: org_study_id
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