Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

This study has been completed.
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01257841
First received: December 7, 2010
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention
Healthy
Drug: Leptin administration
Behavioral: Fasting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hormone levels change from baseline. [ Time Frame: Change from baseline after 4 days of intervention. ] [ Designated as safety issue: No ]
    Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion.


Secondary Outcome Measures:
  • Levels of inflammatory cytokines change from baseline. [ Time Frame: Change from baseline after 4 days of intervention. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fasting alone Behavioral: Fasting
Complete fasting, save for water and multivitamin, for four days.
Active Comparator: Fasting plus leptin Drug: Leptin administration
Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.
Behavioral: Fasting
Complete fasting, save for water and multivitamin, for four days.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01257841

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Institute of Technology
Investigators
Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Steven K Grinspoon, M.D. Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01257841     History of Changes
Other Study ID Numbers: 2002P-000518SA1
Study First Received: December 7, 2010
Last Updated: December 9, 2010
Health Authority: United States: Data Safety Monitoring Board, Massachusetts General Hospital
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Fasting
Gut hormones
Inflammatory Cytokines

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014