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Role of Leptin in the Neuroendocrine and Immune Response to Fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00140231
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Fasting Drug: r-metHuLeptin Other: placebo Phase 1 Phase 2

Detailed 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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans
Study Start Date : October 2002
Primary Completion Date : March 2011
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Metreleptin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Metreleptin
r-metHuLeptin self-administered subcutaneously
Drug: r-metHuLeptin
recombinant human leptin
Other Name: metreleptin
Other: placebo
placebo (no active drug)
Placebo Comparator: Placebo
Placebo, administered in same method as active arm.
Drug: r-metHuLeptin
recombinant human leptin
Other Name: metreleptin
Other: placebo
placebo (no active drug)

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140231

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Principal Investigator: Christos S Mantzoros, MD, DSc Beth Israel Deaconess Medical Center
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christos Mantzoros, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00140231     History of Changes
Other Study ID Numbers: 2002P000049
2M01RR001032-30 ( U.S. NIH Grant/Contract )
5R01DK058785-07 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2005    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Christos Mantzoros, Beth Israel Deaconess Medical Center:
immune function
energy deficiency associated with short-term fasting