Role of Leptin in the Neuroendocrine and Immune Response to Fasting

Beth Israel Lahey Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Fasting

Treatments: Other: placebo; Drug: r-metHuLeptin

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00140231

2002P000049

5R01DK058785-07 (U.S. NIH Grant/Contract)

2M01RR001032-30 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 13 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

Metreleptin

Active Comparator group

Description:

r-metHuLeptin self-administered subcutaneously

Treatment:

Other: placebo

Drug: r-metHuLeptin

Placebo

Placebo Comparator group

Description:

Placebo, administered in same method as active arm.

Treatment:

Other: placebo

Drug: r-metHuLeptin