Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Fasting; Drug: Leptin administration

• Registration Number: NCT01257841
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Status Verified: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-09
• Last Update Submitted: 2010-12-09
• Study First Posted: 2010-12-10
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting alone	Fasting	-
Fasting plus leptin	Leptin administration	-
Fasting plus leptin	Fasting	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Levels of inflammatory cytokines change from baseline.	Change from baseline after 4 days of intervention.

Trial Locations

Locations (2)

Massachusetts Institute of Technology; 🇺🇸 Cambridge, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States