drugset / Trial / NCT01257841

Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

NCT01257841

RandomizedParallel-groupDouble-blind

Summary

The original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid function, and cortisol secretion. The current study is a secondary analysis focussed on the placebo group which underwent a four-day fast. The study is looking at the effects of fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The hypothesis for this secondary analysis was that four days of fasting would augment levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones, while suppressing secretion of inflammatory cytokines.

Timeline

Start
2002-11
Primary completion
2003-12
Completion
2003-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leptin Protein / enzyme biologic 0.05 mg/kg Subcutaneous

Indications

No indication recorded.