Role of Leptin in the Neuroendocrine and Immune Response to Fasting
3 other identifiers
interventional
13
1 country
1
Brief Summary
The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function associated with fasting, which decreases leptin levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2002
Longer than P75 for phase_1
1 active site
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
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
June 7, 2017
CompletedJune 7, 2017
May 1, 2017
8.4 years
August 30, 2005
December 29, 2015
May 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cortisol
four days
ACTH Mean Level
Response of ACTH to leptin administration in fed and fasting state from baseline was measured
4 days
Immune Function CD3 Count
4 days
Secondary Outcomes (3)
%Fat Mass
four days
(RMR)
four days
Autonomic Function
four days
Study Arms (2)
Metreleptin
ACTIVE COMPARATORr-metHuLeptin self-administered subcutaneously
Placebo
PLACEBO COMPARATORPlacebo, administered in same method as active arm.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy lean women (with body mass indices \[BMI\] \< 25 kg/m2)
- Overweight otherwise healthy men (with BMI \> 27 kg/m2)
- Overweight otherwise healthy women (with BMI \> 27 kg/m2).
You may not qualify if:
- A history of any illness that may affect the concentrations of the hormones to be studied, e.g. infectious diseases, renal or hepatic failure, type 1 or type 2 diabetes mellitus, cancer or lymphoma, hypogonadism, malabsorption or malnourishment, hypo- or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, anemia, or eating disorder
- On medications known to affect the hormones to be measured (glucocorticoids, anti-seizure medications, and thyroid hormones)
- A known history of anaphylaxis or anaphylactoid-like reactions, or a known hypersensitivity to E. coli derived proteins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- National Center for Research Resources (NCRR)collaborator
- Amgencollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (6)
Chan JL, Heist K, DePaoli AM, Veldhuis JD, Mantzoros CS. The role of falling leptin levels in the neuroendocrine and metabolic adaptation to short-term starvation in healthy men. J Clin Invest. 2003 May;111(9):1409-21. doi: 10.1172/JCI17490.
PMID: 12727933BACKGROUNDBouzoni 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: 35820631DERIVEDChrysafi 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: 33051459DERIVEDFoo JP, Aronis KN, Chamberland JP, Mantzoros CS. Lack of Day/Night variation in fibroblast growth factor 21 levels in young healthy men. Int J Obes (Lond). 2015 Jun;39(6):945-8. doi: 10.1038/ijo.2014.215. Epub 2014 Dec 26.
PMID: 25540981DERIVEDFoo JP, Aronis KN, Chamberland JP, Paruthi J, Moon HS, Mantzoros CS. Fibroblast growth factor 21 levels in young healthy females display day and night variations and are increased in response to short-term energy deprivation through a leptin-independent pathway. Diabetes Care. 2013 Apr;36(4):935-42. doi: 10.2337/dc12-0497. Epub 2012 Nov 27.
PMID: 23193213DERIVEDMoragianni 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Our study is confined to lean, healthy female subjects; therefore, our results should not be generalized to male, obese,or diabetic subjects
Results Point of Contact
- Title
- Christos Mantzoros
- Organization
- BIDMC
Study Officials
- PRINCIPAL INVESTIGATOR
Christos S Mantzoros, MD, DSc
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- 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
October 1, 2002
Primary Completion
March 1, 2011
Study Completion
December 1, 2016
Last Updated
June 7, 2017
Results First Posted
June 7, 2017
Record last verified: 2017-05