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临床试验/NCT00073242
NCT00073242Unknown3 期

Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2000年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
25
试验地点
1
主要终点
Effects of leptin repletion on hypometabolism/hyperphagia following weight loss

研究概览

简要总结

Our previous studies have demonstrated that there is substantial metabolic opposition to the maintenance of an altered body weight. Leptin is a protein secreted by fat cells and the circulating concentrations of leptin are directly proportional to fat mass. Leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. These studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. The basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or T3 supplementation.

详细描述

We demonstrated a substantial metabolic resistance to maintenance of altered body weight. Leptin is secreted by fat cells in circulating concentrations that are directly proportional to fat mass. Leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. These studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. The basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or T3 supplementation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

leptin repletion

Experimental

Repletion of leptin following weight loss induced by dietary modification.

干预措施: Leptin (Drug)

leptin repletion

Experimental

Repletion of leptin following weight loss induced by dietary modification.

干预措施: Dietary modification (Behavioral)

T3 repletion

Experimental

Repletion of T3 following weight loss induced by dietary modification.

干预措施: Dietary modification (Behavioral)

T3 repletion

Experimental

Repletion of T3 following weight loss induced by dietary modification.

干预措施: T3 repletion (Drug)

结局指标

主要结局

Effects of leptin repletion on hypometabolism/hyperphagia following weight loss

时间窗: 9 months per subject

Subjects are studied at usual weight and during maintenance of a 10% weight reduction while receiving either leptin repletion or a placebo in a single blind crossover design.

次要结局

未报告次要终点

研究者

研究点 (1)

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