NCT00140205

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
11.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

August 30, 2005

Results QC Date

January 6, 2017

Last Update Submit

January 8, 2018

Conditions

Energy Deficiency Due to Short-term Fasting

Keywords

leptinfastingpharmacokinetics

Outcome Measures

Primary Outcomes (18)

  • 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

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (1)

Fed state or fasting state

EXPERIMENTAL

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

Drug: r-metHuLeptin

Interventions

r-metHuLeptinDRUG

r-metreleptin was given in 3 different dose in fed and fasting states

Also known as: Recombinant leptin
Fed state or fasting state

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

  • 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: 35820631DERIVED

  • 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: 33051459DERIVED

  • 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: 21917874DERIVED

  • 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: 21660636DERIVED

  • 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.

    PMID: 20703446DERIVED

Related Links

MeSH Terms

Conditions

Fasting

Interventions

recombinant methionyl human leptin

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Limitations and Caveats

small size population, results cannot be generalized

Results Point of Contact

Title
Dr. Christos mantzoros
Organization
BIDMC
cmantzor@bidmc.harvard.edu
6176671656

Study Officials

  • Christos S Mantzoros, MD DSc FACP FACE

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

February 1, 2001

Primary Completion

June 1, 2004

Study Completion

December 1, 2016

Last Updated

November 2, 2018

Results First Posted

November 2, 2018

Record last verified: 2017-05

Locations

US(1)