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Completed

NCT Number: NCT00140231

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

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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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

r-metHuLeptin

Drug

recombinant human leptin

Other names: metreleptin

Placebo

Other

placebo (no active drug)

Primary outcomes

  1. Cortisol

    Time frame: four days

  2. ACTH Mean Level

    Time frame: 4 days

    Response of ACTH to leptin administration in fed and fasting state from baseline was measured

  3. Immune Function CD3 Count

    Time frame: 4 days

Secondary outcomes

  1. %Fat Mass

    Time frame: four days

  2. (RMR)

    Time frame: four days

    Resting Metabolic rate using calorimetry

  3. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Amgen
  • National Center for Research Resources (NCRR)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans

Important dates

Study start
2002
Primary completion
2011
Study completion
2016
First posted
Sep 1, 2005
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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