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Completed

NCT Number: NCT01257841

Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

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.

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Key information

Conditions

Healthy Behavior Fasting Feeding Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leptin administration

Drug

Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.

Fasting

Behavioral

Complete fasting, save for water and multivitamin, for four days.

Primary outcomes

  1. Hormone levels change from baseline.

    Time frame: 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 outcomes

  1. Levels of inflammatory cytokines change from baseline.

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Massachusetts Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Dec 10, 2010
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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