DRUG
r-metHuLeptin
r-metreleptin was given in 3 different dose in fed and fasting states
Pharmacokinetics of Leptin Administration During Fasting
Status
Completed
Phase
Phase 1
Enrollment
15
Locations
1
Results
Posted
Publications
5
Study summary
What the protocol is testing.
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.
Full detailed description
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. Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 1, 2005
Study start
Feb 2001
Primary completion
Jun 2004
Study completion
Dec 2016
Results posted
Nov 2, 2018
Registry updated
Nov 2, 2018
Outcomes
What the study measures.
Primary outcomes
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
Time frame · 3 DAY
72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Secondary outcomes
Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
Time frame · 1 DAY or DAY 3
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
Time frame · 1 DAY or DAY 3
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
Time frame · day 3 of fasting and day 1 of fed state
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 30 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * healthy men with body mass indices (BMI) \<25 kg/m2) * 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: * 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) * 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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Publications
Results and literature.
PMID 35820631 ↗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 ↗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 ↗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 ↗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 ↗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.
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