drugset / Trial / NCT01275053

In Vivo Leptin Signaling in Humans After Acute Leptin Administration

NCT01275053

Phase 1 Completed 12 enrolled Beth Israel Deaconess Medical Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2002-07
Primary completion
2013-12
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Leptin Protein / enzyme biologic 0.01 mg/kg

Indications