Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Leptin administration
* Behavioral: Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female age 18-35 BMI 20-26.0 eumenorrheic with normal FSH, TSH, Prolactin Hgb > 12 g/dL, normal creatinine normal puberty and development negative pregnancy test. In addition, subjects agreed not to be sexually active during the course of the inpatient study and to use contraception for a period of 48 hours after discharge from the hospital. Exclusion Criteria: medical or endocrine problems known to affect thyroid, reproductive, GH or cortisol function medications known to affect neuroendocrine function prior history of eating disorder or significant menstrual irregularities subjects who have a known hypersensitivity to E. Coli derived protein. subjects with a history of seizure disorder, significant cardiac disease, medication for cardiac disease, or kidney disease history of anaphylaxis or anaphylactoid like reactions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fasting alone<br> | Behavioral: Fasting<br>* Complete fasting, save for water and multivitamin, for four days.<br>|
| Active Comparator: Fasting plus leptin<br> | Drug: Leptin administration<br>* Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.<br>Behavioral: Fasting<br>* Complete fasting, save for water and multivitamin, for four days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone levels change from baseline. | Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion. | Change from baseline after 4 days of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of inflammatory cytokines change from baseline. |  | Change from baseline after 4 days of intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fasting, Gut hormones, Inflammatory Cytokines