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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
r-metreleptin was given in 3 different dose in fed and fasting states
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg
24-hour fed Leptin dose 0.3 mg/kg
Time frame: 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
Time frame: 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
Time frame: 1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg
24-hour fed Leptin dose 0.01 mg/kg
Time frame: 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
Time frame: 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
Time frame: 1 DAY
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg
24-hour fed Leptin dose 0.1 mg/kg
Time frame: 1 DAY
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
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)
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
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)
Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Time frame: day 3 of fasting and day 1 of fed state