Pharmacokinetics of Leptin Administration During Fasting
This trial is active, not recruiting.
|Condition||energy deficiency due to short-term fasting|
|Sponsor||Beth Israel Deaconess Medical Center|
|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.
|Endpoint classification||pharmacokinetics study|
|Intervention model||parallel assignment|
leptin pharmacokinetic parameters
neuroendocrine hormone levels
adipokine hormone levels
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
|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|
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