Leptin in the Maintenance of Reduced Body Weight
Condition: Obesity
MeSH terms: Body Weight
Intervention: Leptin; Placebo
Intervention description: Hormone - daily self injections for 6 months; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 67 Years
Healthy volunteers: No

Summary:

      You are invited to take part in a research study about the role of leptin (a fat cell hormone
      that normally circulates in the blood) on maintaining a reduced body weight. This study will
      also evaluate how leptin impacts hormone levels, metabolic rate (how many calories are used
      at rest), autonomic nervous function (the part of your brain that controls your heart rate
      and breathing), changes in body composition and your sense of appetite. Under normal
      conditions, leptin is secreted by fat cells and signals to the brain to decrease appetite and
      regulate energy usage and hormone levels. When obese individuals lose weight, their leptin
      levels go down, which may cause them to later regain the weight. This study will provide
      leptin as an investigational medication (not yet approved by the Food and Drug
      Administration) to increase the levels of the leptin hormone that normally circulates in your
      blood back to a normal range. We will see if this can help you to maintain your reduced body
      weight and improve your hormonal and metabolic function.
    

Eligibility criteria:

        Inclusion criteria for dietary induced weight loss group:

          -  Age 18 or older

          -  Body mass index (pre weight loss) between 30 and 40 kg/m2.

          -  Weight loss achieved over a period not greater than 6 months.

        Exclusion criteria for dietary induced weight loss group:

          -  Use of a very low calorie diet in the year prior to the start of the study

          -  History of diabetes

          -  History of any illness that may affect the concentrations of the hormones to be
             studied (such as anemia, infectious diseases, renal or hepatic failure, cancer,
             lymphoma, clinically evident hypogonadism, malabsorption or malnourishment, hypo or
             hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)

          -  On medications known to affect the hormones to be measured in this study (such as
             glucocorticoids, anti seizure medications or thyroid hormones), or medications for
             weight loss.

          -  Known history of reactions or known hypersensitivity to E. Coli derived proteins

          -  Breast feeding, pregnant, or wanting to become pregnant during the next year

          -  Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic
             means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic
             infusion pumps, etc.).

          -  Subjects with any type of ferromagnetic bioimplant that could potentially be displaced
             or damaged, such as aneurysm clips, metallic skull plates, etc.

          -  Subjects that exhibit noticeable anxiety and/or claustrophobia.

          -  Subjects who have cardiac or known circulatory impairment, and/or the inability to
             perspire (poor thermoregulatory function).

          -  Subjects who have significant sensory or motor impairment; - Subjects who suffer from
             epilepsy, in particular photo-sensitive epilepsy (this would be a risk for scanning
             with visual stimulation).

          -  Subjects with neurological problems that might interfere or complicate testing (e.g.
             presence of titubation).

          -  Subjects who cannot adhere to the experimental protocol for any reason.

        Inclusion criteria for lap band surgery induced weight loss group:

          -  Age 18 or older.

          -  Body mass index (pre weight loss) between 30 and 40 kg/m2.

          -  Weight loss achieved over a period not greater than 6 months.

          -  Approved for bariatric surgery as per Beth Israel Deaconess Medical Center (BIDMC)
             Bariatric Clinic guidelines

          -  Adult men and women, age 18-65

          -  English speaking

          -  Willing and able to take part in a multi year study involving visits and telephone
             interviews

          -  Enrolled prior to bariatric surgery.

        Exclusion Criteria:

          -  Any condition that would exclude a patient from lap band surgery as listed below -

          -  patients with untreated major depression or psychosis

          -  binge eating disorders

          -  current drug and alcohol abuse

          -  severe cardiac disease with prohibitive anesthetic risks

          -  severe coagulopathy i

          -  inability to comply with nutritional requirements including life-long vitamin
             replacement.

          -  pregnancy

          -  Any additional condition which is not in accordance with standard of care as per
             Bariatric Clinic at BIDMC.

          -  Any condition which in the opinion of the investigators makes the candidate unsuitable
             for participation in this study

          -  Diabetes controlled by medication