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NCT00140231 Clinical Trial

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

Fasting Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00140231
Other study ID # 2002P-000049
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received August 30, 2005
Last updated January 19, 2012
Start date October 2002

Study information
Verified date January 2012
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 24
Est. completion date
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• r-metHuLeptin

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (4)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Amgen, National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chan JL, Heist K, DePaoli AM, Veldhuis JD, Mantzoros CS. The role of falling leptin levels in the neuroendocrine and metabolic adaptation to short-term starvation in healthy men. J Clin Invest. 2003 May;111(9):1409-21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary neuroendocrine hormone levels and pulsatility and immune function No
Secondary body composition No
Secondary resting metabolic rate No
Secondary autonomic function No
Secondary appetite No
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