Effects of Human Leptin Replacement
|ClinicalTrials.gov Identifier: NCT00657605|
Recruitment Status : Unknown
Verified April 2008 by University of Miami.
Recruitment status was: Active, not recruiting
First Posted : April 14, 2008
Last Update Posted : April 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Obesity Metabolic Syndrome Diabetes||Drug: Recombinant methionyl human leptin||Phase 2|
Three separate, but complementary, specific aims, will elucidate the role of leptin in the regulation of (A) the human pituitary-adrenal axis, (B) the human pituitary-gonadal axis, and (C) the human pituitary-thyroid axis. These aims will be approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain the endocrine effects of human leptin. The proposed studies will elucidate key aspects of human endocrine function and will give new insights on the role of leptin in human endocrine regulation.
We also propose to perform structural MRI scans (on and off leptin replacement) to test the association of the changes in brain tissue composition with leptin replacement, and to test how leptin influences regional brain function during the presentation of food-related stimuli (pictures of food), which we will present to the patients along with neutral pictures (e.g., landscapes). We will test how this possible effect on brain function will be related to food craving or hunger.
In yet another part of the study we will assess the kinetics of human recombinant leptin.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Human Leptin Replacement|
|Study Start Date :||June 2001|
|Estimated Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||December 2010|
Three adult patients with congenital leptin deficiency.
Drug: Recombinant methionyl human leptin
Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
- Weight loss [ Time Frame: Before and every 6 months after treatment is initiated, from 2001 to 2010 ]
- Improvement of metabolic parameters [ Time Frame: Before and every 6 months after treatment is initiated, from 2001 to 2010 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657605
|United States, Florida|
|University of Miami Miller School of Medicine, Center on Pharmacogenomics|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Julio Licinio, MD||University of Miami|