A Phase 3 interventional study of Leptin and Dietary modification in Obesity, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Status unknown at 1 site in United States. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-04.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3, Interventional, and Health services research
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.
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.
6,297 studies on the registry are indexed under Obesity; 1,693 are open to participants now.
This study's planned enrollment of 25 is below the median of 78 across 4,879 interventional studies indexed under Obesity.
Browse Obesity studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
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Healthy
Repletion of leptin following weight loss induced by dietary modification.
Drug: Leptin · Behavioral: Dietary modification
Repletion of T3 following weight loss induced by dietary modification.
Behavioral: Dietary modification · Drug: T3 repletion
leptin administration
Also known as: no other names
Subjects lose 10% of body weight via dietary restriction
Also known as: no other name
administer T3
Also known as: no other name
Effects of leptin repletion on hypometabolism/hyperphagia following weight loss
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.
Time frame: 9 months per subject
This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)