NCT00140205|CompletedPhase 1Results
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Sponsor study identifier
interventional
15
1 country
1
Study Start
February 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2004
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2001
Date type not reportedThis date has not been verified as actual or estimated.
June 2004
Actual (reported)August 30, 2005
Actual (reported)September 1, 2005
Actual (reported)December 2016
Actual (reported)November 2, 2018
Actual (reported)Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
72-hour fasting Day 3 Leptin dose 0.01 mg/kg
3 DAY
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
72-hour fasting Day 3 Leptin dose 0.01 mg/kg
3 DAY
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
72-hour fasting Day 3 Leptin dose 0.01 mg/kg
3 DAY
Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
72-hour fasting Day 3 Leptin dose 0.1 mg/kg
3 DAY
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
72-hour fasting Day 3 Leptin dose 0.1 mg/kg
3 DAY
Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
1 DAY or DAY 3
Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
1 DAY or DAY 3
Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
day 3 of fasting and day 1 of fed 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-metreleptin was given in 3 different dose in fed and fasting states
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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.
small size population, results cannot be generalized
Christos S Mantzoros, MD DSc FACP FACE
Beth Israel Deaconess Medical Center
15 participants (actual enrollment reported by the registry).
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
February 2001
Date type not reportedThis date has not been verified as actual or estimated.
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
72-hour fasting Day 3 Leptin dose 0.1 mg/kg
3 DAY
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
72-hour fasting Day 3 Leptin dose 0.3 mg/kg
3 DAY
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
72-hour fasting Day 3 Leptin dose 0.3 mg/kg
3 DAY
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
72-hour fasting Day 3 Leptin dose 0.3 mg/kg
3 DAY
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg
24-hour fed Leptin dose 0.3 mg/kg
1 DAY
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg
24-hour fed Leptin dose 0.3 mg/kg
1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg
24-hour fed Leptin dose 0.3 mg/kg
1 DAY
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg
24-hour fed Leptin dose 0.01 mg/kg
1 DAY
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg
24-hour fed Leptin dose 0.01 mg/kg
1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg
24-hour fed Leptin dose 0.01 mg/kg
1 DAY
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg
24-hour fed Leptin dose 0.1 mg/kg
1 DAY
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg
24-hour fed Leptin dose 0.1 mg/kg
1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg
24-hour fed Leptin dose 0.1 mg/kg
1 DAY
Contact the study team to confirm eligibility.
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.
Primary Completion
June 2004
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
November 2, 2018
Results First Posted
November 2, 2018
Record last verified: 2017-05
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