Pharmacokinetics of Leptin Administration During Fasting

NCT ID: NCT00140205

Last Updated: 2018-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Energy Deficiency Due to Short-term Fasting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type EXPERIMENTAL

r-metHuLeptin

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Recombinant leptin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christos Mantzoros

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 35820631 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33051459 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21917874 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21660636 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20703446 (View on PubMed)

Related Links

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http://www.bidmc.org/

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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