In Vivo Leptin Signaling in Humans After Acute Leptin Administration
Condition: Lean; Obese; Obese Diabetics
MeSH terms: Obesity
Intervention: leptin
Intervention description: 0.01mg/kg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Leptin; In Vivo; Diabetic; Obese; Lean

Summary:

      The purpose of this research study is to help us to better understand how leptin regulates
      blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells.
      Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and
      influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an
      investigational drug and has not yet been approved by the Food and Drug Administration (FDA),
      will be administered to participants in this study. The expected duration of your
      participation is 3 study visits, which will be spread over 3-4 weeks.

      This study involves having fat and muscle biopsies after receiving leptin under local
      anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or
      Endocrinology exam room at the Beth Israel Deaconess Medical Center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For this pilot study we propose to enroll men and women, ages 18-65 years, with body
             mass index (BMI) ranges meeting lean and obese criteria, and less than or equal to 45
             kg/m2. Obese diabetics will also be included.

        Exclusion Criteria:

          -  We will exclude subjects who require special diet prior to biopsy. We will exclude
             subjects with a history of any illness, other than obesity and diabetes. Subjects
             taking any medications that are known to influence glucose metabolism such as
             glucocorticoids will also be excluded. Subjects who have a known history of
             anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E.
             coli-derived proteins or anesthetic agents such as Lidocaine or Novocaine will be
             excluded from the study. Women who are breast feeding, pregnant, or wanting to become
             pregnant during the month following the study may not participate in this study. Women
             participating in this study must use a contraceptive method to prevent pregnancy
             (birth control pills, hormonal implants, intrauterine device (IUD), diaphragm with
             intravaginal spermicide, cervical cap, male or female condom). If a woman suspects
             that she has become pregnant during the study or within one month of completing study,
             or if she does not use one of the contraceptive methods recommended by the
             investigator, she will be instructed to notify the study staff immediately. Subjects
             with a history of bleeding dyscrasia, poor wound healing or any medical condition
             precluding supine position will be excluded from the study.