Fig. 1: Schematic representation of the study designs of the four clinical studies.
From: Leptin alters energy intake and fat mass but not energy expenditure in lean subjects
Study 1: Eight healthy lean men and seven healthy lean women were studied under three separate Clinical Research Center (CRC)-based conditions for 72 h: one under isocaloric fed state conditions (normoleptinemia) and two during complete fasting state conditions (induced hypoleptinemia) scheduled in a random order and in a double-blind fashion with administration of physiologic replacement leptin doses (fasting + leptin) or placebo (fasting + placebo). Study 2: Five lean men, five men with obesity, and five lean women participated in three fed-normoleptinemic and three fasting-induced hypoleptinemic studies, which were conducted in the CRC, with leptin administration at three different doses (Dose A = 0.01 mg/kg, Dose B = 0.1 mg/kg, Dose C = 0.3 mg/kg). Study 3: Open-label long-term leptin treatment in mildly hypoleptinemic women. Study 4: Placebo-controlled long-term leptin treatment in mildly hypoleptinemic women.
