Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

Massachusetts General Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline after 4 days of intervention.

Secondary Outcomes

Levels of inflammatory cytokines change from baseline.

Time frame: Change from baseline after 4 days of intervention.