This trial is active, not recruiting.

Condition energy deficiency due to short-term fasting
Treatment r-methuleptin
Phase phase 1
Sponsor Beth Israel Deaconess Medical Center
Collaborator Amgen
Start date February 2001
End date June 2004
Trial size 28 participants
Trial identifier NCT00140205, 2001-P-000260


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

leptin pharmacokinetic parameters
time frame:

Secondary Outcomes

neuroendocrine hormone levels
time frame:
adipokine hormone levels
time frame:
cytokine levels
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

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

Additional Information

Official title Pharmacokinetics of Leptin Administration During Fasting
Principal investigator Christos S Mantzoros, MD DSc FACP FACE
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.