Energy Deficiency Due to Short-term FastingPhase 1NCT00140205

Pharmacokinetics of Leptin Administration During Fasting

A Phase 1 study testing r-metHuLeptin in people with Energy Deficiency Due to Short-term Fasting, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Energy Deficiency Due to Short-term Fasting
What is being tested?: r-metHuLeptin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Feb 2001to Dec 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Read the 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

Conditions: Energy Deficiency Due to Short-term Fasting
Being tested: r-metHuLeptin
Keywords: leptin, fasting, pharmacokinetics
Medical subject headings: Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

r-metHuLeptinDrug
Also called Recombinant leptin
r-metreleptin was given in 3 different dose in fed and fasting states

Study groups in NCT00140205
Study group	Role	What they receive
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 Receives: Drug: r-metHuLeptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg
24-hour fed Leptin dose 0.3 mg/kg
Measured: 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
Measured: 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
Measured: 1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg
24-hour fed Leptin dose 0.01 mg/kg
Measured: 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
Measured: 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
Measured: 1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg
24-hour fed Leptin dose 0.1 mg/kg
Measured: 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)
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Measured: 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)
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Measured: 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)
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Measured: day 3 of fasting and day 1 of fed state

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2001Dec 2016

First posted1 Sep 2005 (estimated)
Study startFeb 2001
Primary completionJun 2004
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Energy Deficiency Due to Short-term FastingStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00140205
Sponsor's protocol ID: 2001P000260
Status last verified: May 2017
First submitted: 30 Aug 2005
Last updated: 2 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 35820631
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.
PubMed 33051459
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.
PubMed 21917874
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.
PubMed 21660636
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.
PubMed 20703446

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Energy Deficiency on Hormones in Contraceptive Users
Energy Deficiency Due to Short-term Fasting, Hormonal Contraception

All Energy Deficiency Due to Short-term Fasting trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Leptin Administration During Fasting
ClinicalTrials.gov ID: NCT00140205
Acronym / sponsor ID: 2001P000260
Conditions: Energy Deficiency Due to Short-term Fasting
Keywords: leptin, fasting, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: Amgen
Study start: Feb 2001
Primary completion: Jun 2004 (actual)
Study completion: Dec 2016 (actual)
First posted: 1 Sep 2005 (estimated)
Results: Posted 2 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fed state or fasting state	Experimental	Drug: r-metHuLeptin1-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

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
r-metHuLeptinAlso: Recombinant leptinr-metreleptin was given in 3 different dose in fed and fasting states	Drug	Fed state or fasting state

Primary outcome

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
Leptin Pharmacokinetics Parameters - AUC 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 Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.3 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.3 mg/kg
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.3 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.01 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.01 mg/kg
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.01 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg
Time frame: 1 DAY
24-hour fed Leptin dose 0.1 mg/kg

3 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
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
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

Results and safety

Results posted to the registry on 2 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5 LEAN MEN Fasting State (72 Hrs) on 0.3mg/kg Leptin	5	5
5 OBESE MEN 72 HR FASTING on 0.3mg/kg Leptin	5	5
5 LEAN WOMEN 72 HR FATSING on 0.3mg/kg Leptin	5	5

Primary outcome: 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. Mean (Standard Deviation). Unit: HR

Measure	5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg n = 5	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg n = 5	5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg n = 5
TIME(T1/2) DAY 3	1.93 (0.28)	2.75 (1.49)	2.99 (1.01)
TMAX DAY 3	2.00 (0.71)	3.00 (0.71)	2.80 (1.30)

Primary outcome: Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Time frame: 3 DAY. Mean (Standard Deviation). Unit: NG/ML

Measure	5 LEAN MEN Fasting State (72 Hrs) n = 5	5 OBESE MEN 72 HR FASTING n = 5	5 LEAN WOMEN 72 HR FATSING n = 5
c(MAX)	2.60 (0.59)	4.21 (1.17)	4.62 (1.60)
L0 (ENDOGENOUS LEPTIN LEVEL)	1.42 (0.72)	3.32 (1.21)	3.53 (1.26)

Primary outcome: Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Time frame: 3 DAY. Mean (Standard Deviation). Unit: NG*H/ML

Measure	5 LEAN MEN Fasting State (72 Hrs) n = 5	5 OBESE MEN 72 HR FASTING n = 5	5 LEAN WOMEN 72 HR FATSING n = 5
Value	12.27 (2.95)	35.43 (13.81)	47.81 (23.90)

Primary outcome: 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. Mean (Standard Deviation). Unit: HR

Measure	5 LEAN MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg n = 5	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg n = 5	5 LEAN WOMEN (72 Hrs) Fasting - Leptin 0.1 mg/kg n = 5
TIME(T1/2) DAY 3	1.82 (0.58)	3.10 (1.20)	1.73 (0.57)
TMAX DAY 3	3.20 (1.10)	4.00 (1.58)	3.00 (1.00)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fasting State (72 Hrs)	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Limitations and caveats (from the sponsor): small size population, results cannot be generalized

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35820631Bouzoni 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.
Derived from this study: PubMed 33051459Chrysafi 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.
Derived from this study: PubMed 21917874Moragianni 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.
Derived from this study: PubMed 21660636Aronis 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.
Derived from this study: PubMed 20703446Scheer 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.
Click here for more information about the Mantzoros Research Group.Link provided by the sponsor.
Click here for more information about Beth Israel Deaconess Medical Center.Link provided by the sponsor.

Related trials for Energy Deficiency Due to Short-term Fasting

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Energy Deficiency on Hormones in Contraceptive Users
Energy Deficiency Due to Short-term Fasting, Hormonal Contraception

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christos S Mantzoros, MD DSc FACP FACE principal investigator

Beth Israel Deaconess Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing r-metHuLeptin in people with Energy Deficiency Due to Short-term Fasting, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00140205, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (4 listed)

Key exclusion criteria (4 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Primary outcome: Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Primary outcome: Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Primary outcome: Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

Adverse events

Research links

Related trials for Energy Deficiency Due to Short-term Fasting

Energy Deficiency on Hormones in Contraceptive Users

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Primary outcome: Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Primary outcome: Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

Primary outcome: Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

Adverse events