Effects of Leptin Treatment on Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double blind placebo controlled clinical study designed to determine the effects of
      leptin on the changes that occur in the body during weight loss achieved by a very low
      calorie diet.
    

Detailed description: 
      Leptin is a hormone that is produced by the fat tissue and acts on the brain. Leptin plays a
      key role in regulating energy balance and body weight in animals and in humans.

      When a person loses weight, leptin concentration in the blood is reduced. Reduction in blood
      leptin levels has been found to be related to a decreased metabolic rate (the rate in which
      the body burns its calories), an increased appetite, and to many other physiological and
      hormonal changes that may lead to failure in dieting.

      This study is aimed to test if maintaining leptin in the pre-diet level range will ameliorate
      the changes that occur in the body during weight loss. If these changes are reduced, the
      process of weight loss could be easier and faster when adhering to a low calorie diet.

      In this study, leptin or placebo is administered by an injection under the skin, in a way
      that is similar to injections of insulin to diabetic patients. 50% of the subjects
      participating in the study are treated by leptin and 50% are treated by placebo. Blood leptin
      levels are maintained in the pre-diet range in leptin treated subjects by leptin treatment.
      Subjects treated by placebo will also lose weight if they adhere to the liquid diet provided
      by the Rockefeller University Bio-nutrition Department. The investigators and the
      participants don't know if leptin or placebo are used since this is a double blind study.

      To participate in this study, subjects have to stay at the Rockefeller University Hospital as
      inpatients for about two months and continue the study as outpatients for 4 more months.
      During the outpatient period, subjects have to attend a clinic visit once a week. During the
      first 3 weeks of the study, subjects are introduced to a weight stabilization liquid diet.
      During this time, the initial weight is maintained and baseline study tests are performed.
      When testing is completed, a very low calorie liquid diet and leptin or placebo
      administration are initiated. Weight is monitored until 10% weight loss is achieved. At this
      time, a second testing period is performed in an inpatient setting. When testing is
      completed, weight loss and leptin or placebo treatment continue at home in an outpatient
      setting until 20% weight loss is achieved. When this period is completed, a third testing
      period is performed in an inpatient setting. The last month of the study is dedicated to a
      transition from the liquid diet to solid food, and to weight maintenance education provided
      by the hospital staff in an outpatient setting. A solid food weight maintenance diet is
      provided to participants during this period. At the end of this period, two days of testing
      are performed and leptin/placebo administration is discontinued.

      Study testing periods are performed over 12 days in an inpatient setting and include a
      variety of blood draws, urine collection, and metabolic and behavioral tests that are known
      to be affected by weight loss.
    

Intervention name(s): Leptin; Very Low Calorie Diet
Intervention type(s): Drug; Behavioral
Intervention description(s): Leptin is an adipocyte hormone that functions as an afferent signal in a feedback loop regulating body weight; placebo injections
Other intervention name(s): A-100; Recombinant-methionyl Human Leptin (r-metHuLeptin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Weightloss; Leptin; Diet; Reducing; Overweight; Fat