Pharmacokinetics of Leptin Administration During Fasting

Completed · Phase 1

Conditions studied: Energy Deficiency Due to Short-term Fasting

In brief

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.

Key facts

Study ID

NCT00140205

Run by

Beth Israel Deaconess Medical Center

People needed

15

Starts

2001-02-01

Expected to finish

2016-12-01

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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