Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02215


Purpose:

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.


Study summary:

Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to decrease appetite and increase energy use. Leptin levels usually go down with fasting. This study will evaluate the secretion of an investigational agent called leptin in lean and overweight individuals while fasting and investigate the potential role of leptin as a regulator of immune function and mediator of the neuroendocrine response to food deprivation in humans. Data derived from these studies will provide insights into the mechanisms underlying altered hormone levels and immune function in malnutrition and obesity and thus may provide the basis for future therapeutic interventions for obesity. Comparison: fed state vs. fasting state vs. fasting + leptin state


Criteria:

Inclusion Criteria: - 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). Exclusion Criteria: - 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


NCT ID:

NCT00140231


Primary Contact:

Principal Investigator
Christos S Mantzoros, MD, DSc, FACP, FACE
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.