This trial is active, not recruiting.

Condition fasting
Treatment r-methuleptin
Phase phase 1/phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2002
End date October 2012
Trial size 24 participants
Trial identifier NCT00140231, 2002P-000049


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

neuroendocrine hormone levels and pulsatility and immune function
time frame:

Secondary Outcomes

body composition
time frame:
resting metabolic rate
time frame:
autonomic function
time frame:
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

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

Additional Information

Official title Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans
Principal investigator Christos S Mantzoros, MD, DSc, FACP, FACE
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.