DRUG
r-metHuLeptin
recombinant human leptin
Status
Completed
Phase
Phase 1 / Phase 2
Enrollment
13
Locations
1
Results
Posted
Publications
7
Study summary
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.
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
Interventions
DRUG
recombinant human leptin
OTHER
placebo (no active drug)
Timeline
First posted
Sep 1, 2005
Study start
Oct 2002
Primary completion
Mar 2011
Study completion
Dec 2016
Results posted
Jun 7, 2017
Registry updated
Jun 7, 2017
Outcomes
Cortisol
Time frame · four days
ACTH Mean Level
Time frame · 4 days
Response of ACTH to leptin administration in fed and fasting state from baseline was measured
Immune Function CD3 Count
Time frame · 4 days
%Fat Mass
Time frame · four days
(RMR)
Time frame · four days
Resting Metabolic rate using calorimetry
Autonomic Function
Time frame · four days
aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Publications
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