Role of Leptin in the Neuroendocrine and Immune Response to Fasting

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metreleptin

r-metHuLeptin self-administered subcutaneously

Group Type ACTIVE_COMPARATOR

r-metHuLeptin

Intervention Type DRUG

recombinant human leptin

placebo

Intervention Type OTHER

placebo (no active drug)

Placebo

Placebo, administered in same method as active arm.

Group Type PLACEBO_COMPARATOR

r-metHuLeptin

Intervention Type DRUG

recombinant human leptin

placebo

Intervention Type OTHER

placebo (no active drug)

Interventions

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r-metHuLeptin

recombinant human leptin

Intervention Type DRUG

placebo

placebo (no active drug)

Intervention Type OTHER

Other Intervention Names

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metreleptin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes