Conditions: Energy Deficiency Due to Short-term Fasting
Keywords: leptin fasting pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: yes

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.

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

Arms:
arm 1: 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

Interventions: intervention 1: r-metHuLeptin
Intervention descriptions: intervention 1: r-metreleptin was given in 3 different dose in fed and fasting states

Protocol document: