Role of Leptin in the Neuroendocrine and Immune Response to Fasting

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Fasting

In brief

The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function associated with fasting, which decreases leptin levels.

Key facts

Study ID

NCT00140231

Run by

Beth Israel Deaconess Medical Center

People needed

13

Starts

2002-10-01

Expected to finish

2016-12-01

Last updated by the study team

2017-06-07

Who can join

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

You may qualify if…

• Healthy lean women (with body mass indices [BMI] < 25 kg/m2)
• Overweight otherwise healthy men (with BMI > 27 kg/m2)
• Overweight otherwise healthy women (with BMI > 27 kg/m2).

You may not qualify if…

• A history of any illness that may affect the concentrations of the hormones to be studied, e.g. infectious diseases, renal or hepatic failure, type 1 or type 2 diabetes mellitus, cancer or lymphoma, hypogonadism, malabsorption or malnourishment, hypo- or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, anemia, or eating disorder
• On medications known to affect the hormones to be measured (glucocorticoids, anti-seizure medications, and thyroid hormones)
• A known history of anaphylaxis or anaphylactoid-like reactions, or a known hypersensitivity to E. coli derived proteins

Where it is running

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

Full record on ClinicalTrials.gov

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