Phase 2
N=13
Role of Leptin in the Neuroendocrine and Immune Response to Fasting
Fasting
Bottom Line
View on ClinicalTrials.gov: NCT00140231 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Cortisol — 17.5; 16.9 ug/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- r-metHuLeptin (Drug); placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cortisol |
17.5; 16.9 | — |
| PRIMARY ACTH Mean Level |
10.48; 9.33; 9.89; 8.74 | — |
| PRIMARY Immune Function CD3 Count |
302; 838 | — |
| SECONDARY %Fat Mass |
29.1; 29.3 | — |
| SECONDARY (RMR) |
1.344; 1.352 | — |
| SECONDARY Autonomic Function |
132; 112; 66.1; 66.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy lean women (with body mass indices [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
Data sourced from ClinicalTrials.gov (NCT00140231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.