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Completed

NCT Number: NCT00140205

Pharmacokinetics of Leptin Administration During Fasting

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.

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Key information

Conditions

Energy Deficiency Due to Short-term Fasting Behavior Fasting Feeding Behavior

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

r-metHuLeptin

Drug

r-metreleptin was given in 3 different dose in fed and fasting states

Other names: Recombinant leptin

Primary outcomes

  1. Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.01 mg/kg

  2. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.01 mg/kg

  3. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.01 mg/kg

  4. Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.1 mg/kg

  5. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.1 mg/kg

  6. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.1 mg/kg

  7. Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.3 mg/kg

  8. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.3 mg/kg

  9. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg

    Time frame: 3 DAY

    72-hour fasting Day 3 Leptin dose 0.3 mg/kg

  10. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.3 mg/kg

  11. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.3 mg/kg

  12. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.3 mg/kg

  13. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.01 mg/kg

  14. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.01 mg/kg

  15. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.01 mg/kg

  16. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.1 mg/kg

  17. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.1 mg/kg

  18. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg

    Time frame: 1 DAY

    24-hour fed Leptin dose 0.1 mg/kg

Secondary outcomes

  1. Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)

    Time frame: 1 DAY or DAY 3

    Data were collected neither in Fed nor in Fasting state for the different doses of leptin

  2. Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)

    Time frame: 1 DAY or DAY 3

    Data were collected neither in Fed nor in Fasting state for the different doses of leptin

  3. Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)

    Time frame: day 3 of fasting and day 1 of fed state

    Data were collected neither in Fed nor in Fasting state for the different doses of leptin

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Amgen

Registry information

Important dates

Study start
2001
Primary completion
2004
Study completion
2016
First posted
Sep 1, 2005
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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